DRUG SAFETY

FDA Has Improved Its 

Foreign Drug 

Inspection Program, 

but Needs to Assess 

the Effectiveness and 

Staffing of Its Foreign 

Offices

Report to the Committee on Energy and 

Commerce

December 2016

GAO-17-143

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-17-143, a report to the

Committee on Energy and Commerce

December 2016

DRUG SAFETY

FDA Has Improved Its Foreign Drug Inspection 

Program, but Needs to Assess the 

Effectiveness and Staffing of Its Foreign 

Offices

What GAO Found

The Food and Drug Administration (FDA), an agency within the Department of 

Health and Human Services (HHS), has increased its foreign drug inspections 

and enhanced its ability to prioritize drug establishments for inspection. The 

number of foreign inspections has consistently increased each year since fiscal 

year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than 

domestic inspections. FDA has also improved the accuracy and completeness of 

information on its catalog of drug establishments subject to inspection. It has 

also reduced its catalog of drug establishments with no inspection history to 33

percent of foreign establishments, compared to 64 percent in 2010. However, the 

number of such establishments remains large, at almost 1,000 of the 

approximately 3,000 foreign establishments. FDA plans to inspect all of these

establishments over the next 3 years. 

Total Number of Food and Drug Administration (FDA) Inspections of Domestic and Foreign 

Drug Establishments, Fiscal Year 2007 through June 30, 2016

FDA has not yet assessed its foreign offices’ contributions to drug safety. FDA 

has made progress in its strategic planning for its offices in China, Europe, India, 

and Latin America, but the lack of an assessment is inconsistent with federal 

standards for internal controls. Though FDA uses two performance measures to 

assess the foreign offices—number of medical product inspections and number 

of collaborative actions—the collaborative action measure does not capture the 

offices’ unique contributions to drug safety. Moreover, the foreign offices face 

persistently high vacancy rates. As of July 2016, 46 percent of the foreign offices’ 

authorized positions were vacant. Although FDA recently finalized a workforce 

plan, GAO identified several weaknesses with it. For example, the plan sets a 

workforce target that applies to both foreign and domestic international program 

offices, making it difficult to ascertain whether its goal of reducing foreign office 

staff vacancies is being met. View GAO-17-143. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.

Why GAO Did This Study

Globalization has complicated FDA’s 

oversight of drugs marketed in the 

United States. FDA reports that more 

than 40 percent of finished drugs and 

80 percent of active pharmaceutical 

ingredients are produced overseas. 

FDA inspects drug manufacturing 

establishments to ensure that the 

safety and quality of drugs are not 

jeopardized by poor manufacturing 

practices. Beginning in 2008, FDA 

established foreign offices to obtain 

better information on products coming 

from overseas and perform 

inspections, among other things.

In 2008 and 2010, GAO examined 

FDA’s foreign drug inspection program 

and recommended it conduct more 

foreign inspections. In another 2010 

report, GAO recommended the agency 

develop strategic and workforce plans 

for its foreign offices. GAO was asked 

to update its work with a focus on 

FDA’s oversight of foreign drug 

establishments. This study examines 

(1) enhancements FDA has made to its 

foreign drug inspection program; and 

(2) FDA’s assessment of its foreign 

offices, and the challenges they face in 

ensuring drug safety. GAO analyzed 

FDA’s inspection data from fiscal year 

2007 through June 30, 2016; reviewed 

agency planning documents; and 

interviewed FDA officials, including

former foreign office employees. 

What GAO Recommends

GAO recommends that FDA assess 

the contributions of the foreign offices, 

and set a goal that distinguishes 

between the vacancy rates of staff in 

its foreign offices and those in its 

domestic international program office.

HHS agreed with GAO’s 

recommendations.
Page i GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Letter 1

Background 6

FDA Has Increased Its Foreign Drug Inspections and Enhanced 

Its Ability to Prioritize Drug Establishments for Inspection 13

FDA Has Not Yet Assessed Its Foreign Offices’ Contributions to 

Drug Safety, and Their Efforts are Impeded by High Vacancy 

Rates 25

Conclusions 40

Recommendations for Executive Action 42

Agency Comments and Our Evaluation 42

Appendix I Types of Foreign Drug Establishment Inspections Conducted, Fiscal 

Year 2010 through June 30, 2016 44

Appendix II Drug Establishments that the Food and Drug Administration May 

Never Have Inspected 45

Appendix III Number of Foreign Drug Inspections in which Temporary 

Duty Staff Participated 46

Appendix IV Efforts by the Food and Drug Administration’s Foreign Offices to 

Enhance Drug Safety 47

Appendix V Comments from the Department of Health and Human Services 49

Appendix VI GAO Contact and Staff Acknowledgments 55

Related GAO Products 56

Contents
Page ii GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Tables

Table 1: Total Number of Food and Drug Administration (FDA) 

Drug Inspections of Foreign Establishments, by Country, 

Fiscal Year (FY) 2010 through June 30, 2016 18

Table 2: Total Number of Food and Drug Administration (FDA) 

Drug Inspections in which Foreign Office Investigators 

Participated, Fiscal Year (FY) 2010 through June 30, 

2016 27

Table 3: Number of Authorized and Vacant Positions in the Food 

and Drug Administration’s (FDA) Foreign Offices, by 

Office and Position-Type, as of July 2016 33

Table 4: Food and Drug Administration’s (FDA) Foreign Drug 

Establishment Inspections by Type of Inspection, Fiscal 

Year (FY) 2010 through June 30, 2016 44

Table 5: Drug Establishments in the Food and Drug 

Administration’s (FDA) Fiscal Year 2017 Catalog That 

May Never Have Been Inspected, by Country 45

Table 6: Number of Drug Inspections in which Temporary Duty 

Staff Assigned to the Food and Drug Administration’s 

(FDA) Foreign Offices Participated, Fiscal Year (FY) 2012 

through June 30, 2016 46

Table 7: Food and Drug Administration (FDA) Examples of 

Foreign Office Activities that May Have Resulted in 

Increased Drug Safety 47

Figures

Figure 1: Geographic Responsibilities of the Food and Drug 

Administration’s (FDA) Foreign Offices, Including Their 

Locations, as of October 2016 12

Figure 2: Total Number of Food and Drug Administration (FDA) 

Inspections of Domestic and Foreign Drug 

Establishments, Fiscal Year 2007 through June 30, 2016 15

Figure 3: Food and Drug Administration (FDA) Inspections of 

Foreign Drug Establishments by Type of Inspection, 

Fiscal Year 2010 through June 30, 2016 19

Figure 4: Filled and Vacant Staff Positions at the Food and Drug 

Administration’s (FDA) Foreign Offices, as of July 2016 32
Page iii GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Abbreviations

API active pharmaceutical ingredient

CDER Center for Drug Evaluation and Research

CGMP current good manufacturing practice

D-U-N-S® Data Universal Numbering System 

eDRLS electronic Drug Registration and Listing System 

FACTS Field Accomplishments and Compliance Tracking 

System

FDA Food and Drug Administration

FDASIA Food and Drug Administration Safety and 

Innovation Act

GDUFA Generic Drug User Fee Amendments Act

HHS Department of Health and Human Services

OIP Office of International Programs

ORA Office of Regulatory Affairs

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

441 G St. N.W.

Washington, DC 20548

December 16, 2016

The Honorable Fred Upton

Chairman

The Honorable Frank Pallone Jr.

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Tim Murphy

Chairman

The Honorable Diana DeGette

Ranking Member

Subcommittee on Oversight and Investigations

Committee on Energy and Commerce

House of Representatives

Oversight of the nation’s drug supply chain has become increasingly 

complicated for the Food and Drug Administration (FDA), an agency 

within the Department of Health and Human Services (HHS). Much of the 

U.S. drug supply is manufactured overseas. FDA estimates that nearly 40 

percent of finished drugs and approximately 80 percent of active 

pharmaceutical ingredients (API) are manufactured in registered 

establishments in more than 150 countries; yet, the agency is responsible 

for overseeing the safety and effectiveness of all drugs marketed in the 

United States, regardless of where they are produced.1 As testing a drug 

at the border cannot reliably determine whether drugs were manufactured 

in compliance with current good manufacturing practice (CGMP) 

regulations, FDA conducts several types of inspections of establishments 

that manufacture drugs for the U.S. market.2 FDA began opening offices 

 1

Drugs are defined to include, among other things, articles intended for use in the 

diagnosis, cure, mitigation, treatment, or prevention of disease, and include components 

of those articles. 21 U.S.C. §§ 321(g)(1)(B), (D). An API is any component that is intended 

to provide pharmacological activity or other direct effect in the diagnosis, cure, mitigation, 

treatment, or prevention of disease. In this report, we refer both to drug products—drugs 

in their finished dosage forms—and to APIs as “drugs.” Establishments marketing their 

products in the United States are required to register annually with FDA.

2

CGMPs provide for systems that assure proper design, monitoring, and control of 

manufacturing processes and facilities. See 21 C.F.R. pts. 210, 211, 212 (2016). FDA 

defines manufacturing to include the manufacture, preparation, propagation, compounding 

or processing of a drug. 21 C.F.R. § 207.3(a)(8) (2016). 

Letter
Page 2 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

around the world in 2008 to obtain better information on the increasing 

number of products coming into the United States from overseas, to build 

relationships with foreign stakeholders, and to perform inspections.

We have had long-standing concerns with FDA’s role in the increasingly 

global pharmaceutical supply chain. In 1998, we reported that FDA had 

significant problems managing its foreign inspection data and conducted 

infrequent inspections of foreign establishments.3 Ten years later, in 

2008, we determined that, because of inaccurate information in FDA’s 

databases, the agency did not know how many foreign drug 

establishments were subject to inspection. In addition, we found that FDA 

continued to inspect relatively few foreign establishments, and that most 

such inspections were performed in response to an application to market 

a new drug in the United States, rather than to assess the continued 

quality of drugs already on the market.4 In January 2009, we added 

FDA’s oversight of medical products (i.e., drugs and medical devices) to 

our High-Risk Series, citing FDA’s inability to ensure the quality of 

medical products manufactured overseas as an area of particular 

concern.5 Although we found that FDA was conducting more inspections 

of foreign establishments in 2010, we also reported that many 

establishments may never have been inspected.6 We also identified 

shortcomings in the operations of the agency’s foreign offices in that year 

and again in 2015, raising questions about their effectiveness.7

 3

See GAO, Food and Drug Administration: Improvements Needed in the Foreign Drug 

Inspection Program, GAO/HEHS-98-21 (Washington, D.C.: Mar. 17, 1998). 

4

See GAO, Drug Safety: Better Data Management and More Inspections Are Needed to 

Strengthen FDA’s Foreign Drug Inspection Program, GAO-08-970 (Washington, D.C.: 

Sept. 22, 2008). 

5

See GAO, High-Risk Series: An Update, GAO-09-271 (Washington, D.C.: January 2009). 

6

See GAO, Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to 

Improve Its Information on Foreign Establishments, but More Progress is Needed,

GAO-10-961 (Washington, D.C.: Sept. 30, 2010). For a list of related reports, see the 

Related GAO Products page at the end of this report.

7

See GAO, Food and Drug Administration: Overseas Offices Have Taken Steps to Help 

Ensure Import Safety, but More Long-Term Planning Is Needed, GAO-10-960 

(Washington, D.C.: Sept. 30, 2010); and Food Safety: Additional Actions Needed to Help 

FDA’s Foreign Offices Ensure Safety of Imported Food, GAO-15-183 (Washington D.C.: 

Jan. 30, 2015). Our 2010 report focused on the foreign offices’ efforts to help ensure the 

safety of imported products, such as food and medical products, while our 2015 report 

specifically focused on their contributions related to the safety of imported food.
Page 3 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Given the persistent challenge of globalization for FDA, you asked us to 

provide an update on the agency’s activities and accomplishments related 

to its foreign drug inspection program and the operations of its foreign 

offices. This report examines

1. the enhancements FDA has made to its foreign drug inspection 

program in recent years; and

2. FDA’s assessment of its foreign offices, and the challenges the 

foreign offices face in ensuring drug safety.

To examine the enhancements FDA has made to its foreign drug 

inspection program in recent years, we reviewed FDA’s process for 

prioritizing and selecting establishments for inspections, including 

whether it incorporated certain factors into its selection process as 

required in 2012 by the Food and Drug Administration Safety and 

Innovation Act (FDASIA).8 We also interviewed FDA officials about the 

sources of data the agency uses in this process, including any steps FDA 

may have taken to improve the completeness and accuracy of its data on 

foreign drug establishments. Additionally, we analyzed data from FDA’s 

Field Accomplishments and Compliance Tracking System (FACTS), 

which contains information on the number of the agency’s establishment 

inspections. Specifically, we examined FACTS data from fiscal year 2010 

through June 30, 2016, to determine: (1) the number of foreign and 

domestic inspections conducted by FDA, (2) the type of inspections, and 

(3) the country in which the inspections took place. We also reviewed 

FACTS data presented in one of our prior reports on drug manufacturing 

establishment inspections conducted from fiscal years 2007 to 2009.9 To 

assess the reliability of the data from FACTS, we reviewed related 

documentation, interviewed knowledgeable agency officials, and 

compared the data to published information from the same database. On 

the basis of these steps, we found these data sufficiently reliable for the 

purposes of our reporting objectives. We also reviewed relevant 

documentation related to FDA’s inspections of foreign drug 

establishments, including staffing and funding information. To learn more 

about FDA’s foreign drug inspection program, including the agency’s

 8

Pub. L. No. 112-144, § 705, 126 Stat. 993, 1066 (2012) (codified in pertinent part at 21 

U.S.C. § 360(h)(4)). 

9

GAO-10-961 included information on drug manufacturing establishment inspections 

conducted from fiscal years 2007 to 2009. For this report, we focused on drug 

manufacturing establishment inspections conducted from fiscal years 2010 through June 

30, 2016, which were the most recently available data at the time we did our work.
Page 4 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

progress toward improving its information on foreign drug establishments 

and changes to the agency’s approach to selecting and prioritizing drug 

establishment inspections, we interviewed officials from the Office of 

Regulatory Affairs (ORA), who are responsible for conducting inspections 

of foreign drug establishments, and from the Center for Drug Evaluation 

and Research (CDER), who are responsible for determining which 

establishments need inspection.

Our work focused on human drugs regulated by CDER and not on most 

biologics, medical devices, veterinary medicines, or other items or 

products for which FDA conducts inspections.10 Further, our work focused 

on activities related specifically to the foreign drug inspection program. As 

part of its oversight of imported drugs, FDA undertakes other activities, 

such as working toward international harmonization of regulatory 

requirements, which are beyond the scope of our review.

To examine FDA’s assessment of its foreign offices and the challenges 

the foreign offices face in contributing to the safety of drugs entering the 

United States, we reviewed documents pertaining to the foreign offices 

and their activities provided by FDA’s Office of International Programs 

(OIP), of which the foreign offices are a part and which is responsible for 

overseeing FDA’s overseas activities. Specifically, we examined OIP’s 

strategic plan and strategic workforce plan for the foreign offices to 

identify the offices’ goals, mission, and desired long-term results. We also 

reviewed the operational plans of the foreign offices, which are completed 

quarterly by each office and include the performance measures and 

targets used to assess their activities.11 We also reviewed the report of a 

 10Biologics are materials, such as viruses, therapeutic sera, toxins, antitoxins, vaccines or 

analogous products to prevent, treat, or cure human diseases or injuries, and are derived 

from natural sources, such as humans, animals, and microorganisms. See 42 U.S.C. § 

262(i); 21 C.F.R. § 600.3(h) (2016). Medical devices include instruments, apparatuses, 

machines, and implants that are intended for use to diagnose, cure, treat, or prevent 

disease, or to affect the structure or any function of the body. 21 U.S.C. § 321(h). Our 

work focused on inspections related to the drug approval process or inspections 

conducted to determine an establishment’s ongoing compliance with laws and regulations 

in the manufacture of human drugs already marketed in the United States. FDA conducts 

additional drug inspections that are beyond the scope of our review, such as inspections 

conducted to determine whether drug manufacturers are submitting to FDA, as required, 

complete and accurate data on adverse drug experiences associated with marketed 

drugs, inspections conducted for the President’s Emergency Plan for AIDS Relief, and 

inspections of clinical trial sites, compounding pharmacies, and medical gas 

manufacturers.

11A performance measure is a means of objectively assessing the outputs or outcomes of 

programs, products, projects, or services.
Page 5 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

contractor retained by FDA to develop new performance measures for the 

foreign offices, as well as data from FDA’s agency-wide performance 

tracking system, including some of the agency’s performance measures 

and outcomes. We examined documentation pertaining to FDA’s policies 

and procedures for staff deploying to and returning from the foreign 

offices, including materials related to the reintegration of staff into FDA’s 

domestic offices upon their completion of their terms abroad.

Additionally, we analyzed the most recently complete FDA data on the 

number and type of authorized, filled, and vacant positions for each of 

OIP’s foreign and domestic offices, as well as data on the number of staff 

assigned to the foreign offices on a temporary basis. This included data 

on the number of drug inspections conducted by foreign office personnel. 

To supplement this information, we interviewed FDA officials in OIP, 

which includes the China, India, Latin America, and Europe foreign 

offices, as well as officials in CDER and ORA, to obtain information on the 

foreign offices’ contributions to drug safety and how these contributions 

are assessed by the agency. In addition, we interviewed 13 former foreign 

office staff who had responsibilities pertaining to drug safety—including 

those who were still with FDA and those who have since left the agency—

about their experiences deploying to and working overseas, and, in some 

cases, returning to a domestic post with the agency. Finally, to identify 

criteria to evaluate FDA’s assessment of its foreign offices’ performances, 

we reviewed our previous reports on performance measures and 

standards for internal control in the federal government.12

We conducted this performance audit from February 2016 to December 

2016 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

 12See GAO, Human Capital: Key Principles for Effective Strategic Workforce Planning, 

GAO-04-39 (Washington, D.C.: Dec. 11, 2003). Strategic workforce planning is an 

essential tool to help agencies align their workforces with their current and emerging 

missions and develop long-term strategies for acquiring, developing, and retaining staff. 

See also GAO, Standards for Internal Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: September 2014). Internal control is a process affected by an entity’s 

oversight body, management, and other personnel that provides reasonable assurance 

that the objectives of an entity will be achieved.
Page 6 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Several FDA centers and offices play key roles in helping to ensure the 

safety and effectiveness of drugs marketed in the United States:

• CDER establishes standards for the safety, quality, and effectiveness 

of and manufacturing processes for over-the-counter and prescription 

drugs.13

• OIP, which is part of FDA’s Office of Global Regulatory Operations 

and Policy, leads, manages, and coordinates FDA’s foreign offices’

activities, such as performing inspections in the countries in which the 

offices reside. OIP also engages with international health and 

regulatory partners on a variety of issues, including establishing 

confidentiality agreements with regulatory counterparts for sharing 

information on regulated products, and collaborates with the staff in 

FDA’s centers and ORA.

• ORA inspects establishments and reviews imported products offered 

for entry into the United States to ensure compliance with applicable 

laws and regulations, among other things. ORA is also part of FDA’s 

Office of Global Regulatory Operations and Policy.

FDA conducts several types of inspections of drug manufacturing 

establishments to protect the drug supply. Drugs manufactured overseas 

must generally meet the same statutory and regulatory requirements as 

those produced in the United States.14 CDER and ORA are primarily 

responsible for the agency’s human drug inspection program. CDER 

requests ORA to inspect both domestic and foreign establishments to 

ensure that drugs are produced in conformance with federal statutes and 

regulations, including CGMP regulations. ORA investigators (based 

domestically and in the foreign offices) and, as needed, laboratory 

analysts are responsible for conducting the inspections.15 Investigators 

 13For purposes of this report, we consider drug quality to be a component of drug safety.

Our references to drug safety are therefore meant to also encompass drug quality.

14FDA defines manufacturing to include the manufacture, preparation, propagation, 

compounding, or processing of a drug, and an establishment as a place of business under 

one management at one general physical location. 21 C.F.R. §§ 207.3(a)(7), (8) ( 2016). 

In this report, establishments may be engaged in the manufacture, preparation, 

propagation, or processing of drugs.

15ORA investigators lead inspections and are responsible for performing or overseeing all 

aspects of an inspection. ORA laboratory analysts are chemists or microbiologists and 

have expertise in laboratory testing. In some instances, staff from CDER may participate 

in inspections. ORA assists the agency’s other product centers in planning establishment 

inspections of other FDA-regulated commodities, such as veterinary medicines and food.

Background

Types of Drug Inspections
Page 7 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

generally conduct three types of drug manufacturing establishment 

inspections:

1. Preapproval inspections of domestic and foreign establishments may 

be conducted before FDA approves a new drug to be marketed in the 

United States. These inspections are triggered by FDA’s receipt of a 

new drug application or an abbreviated new drug application, and 

focus on the manufacture of a specific drug. Preapproval inspections 

are designed to verify the accuracy and authenticity of the data 

contained in these applications to determine that the establishment is 

following commitments made in the application. Preapproval 

inspections also assess whether the establishment can manufacture 

the product in the application in conformance with CGMPs. FDA’s 

decision to inspect a particular establishment listed on the application 

is based on multiple factors, including the establishment’s compliance 

history—that is, the results of previous inspections, product recalls, 

and other compliance information—and the attributes of the product 

being proposed for manufacture.

2. Surveillance inspections are conducted at establishments after drugs 

are already marketed in the United States and focus on compliance 

with system-wide controls for ensuring that the manufacturing 

processes produce high-quality drugs. Establishments are prioritized 

for surveillance inspections through a process using a risk-based site 

selection model. Systems examined during these inspections include 

those related to materials, quality control, production, facilities and 

equipment, packaging and labeling, and laboratory controls. These 

systems may be involved in the manufacture of multiple drugs.16 FDA 

can use the results of a surveillance inspection to make decisions in 

the future if the establishment is listed on another application, as the 

results of a surveillance inspection can often be generalized to all 

drugs manufactured in a similar manner at a particular establishment.

3. For-cause inspections are conducted to investigate consumer 

complaints, reports of product quality defects submitted by consumers 

or health care professionals, or indications of potential manufacturing 

problems submitted by the manufacturers themselves through field 

alert reports, among other reasons. Additionally, these inspections 

 16Although surveillance inspections focus on system-wide controls, FDA considers nearly 

all drug establishment inspections to include an assessment of CGMPs.
Page 8 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

may also be conducted as follow-up to warning letters or import alerts 

issued to manufacturers.17

While FDA may conduct a preapproval-only inspection or a surveillanceonly inspection, FDA may also conduct an inspection that combines both 

preapproval and surveillance inspection components in a single visit to an 

establishment.18

FDA uses multiple databases to select foreign and domestic 

establishments for surveillance inspections, including

• The electronic Drug Registration and Listing System (eDRLS) 

contains information on foreign and domestic drug establishments that 

have registered with FDA to market their drugs in the United States.

Establishments are required to register annually with FDA. Information 

in eDRLS includes the company’s name, address, and the drugs they 

manufacture for commercial distribution in the United States, as 

reported by the establishment.

• FACTS contains information on domestic and foreign establishments 

inspected by ORA, the type of inspection conducted, and the outcome 

of those inspections. Investigators and laboratory analysts enter 

information into FACTS following completion of an inspection.

CDER relies on these and other databases to select establishments for 

surveillance inspections.19 CDER primarily uses data from eDRLS, which 

provides information on all registered establishments at a given point in 

time, and FACTS, which provides information about additional 

establishments that may not appear in eDRLS, to annually compile a 

 17A warning letter is a letter that notifies industry about violations that FDA has 

documented during its inspections. Warning letters are to be issued for violations of 

regulatory significance, i.e., those that may actually lead to an enforcement action if the 

documented violations are not promptly and adequately corrected. An import alert informs 

FDA field staff and the public that the agency has enough evidence to allow for detention 

without physical examination of products that appear to be in violation of FDA laws and 

regulations.

18Most combined inspections occur when FDA conducts a surveillance inspection at an 

establishment where a preapproval inspection was also being conducted.

19Other databases FDA uses to select establishments for inspection include the 

Operational and Administrative System for Import Support, which includes data on the 

number of establishments that have manufactured products that were shipped to the 

United States, and the FDA Inventory of Assets, which includes data on establishments 

producing products regulated by FDA.

FDA’s Process for 

Prioritizing Establishments 

for Surveillance Inspection
Page 9 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

catalog of establishments that are to be prioritized for inspection.20

Because the establishments to be prioritized are continuously changing 

as they begin, stop, or resume marketing products in the United States, 

FDA does not maintain a single list of them; rather, the annual catalog 

provides a snapshot in time of such establishments. Based on these 

databases, as of June 2016, CDER’s catalog consisted of approximately 

2,000 domestic and 3,000 foreign drug establishments.

Until 2012, requirements governing FDA’s selection of domestic and 

foreign establishments to inspect differed. Until then, FDA was required to 

inspect domestic establishments that manufacture drugs marketed in the 

United States every 2 years, but there was no comparable requirement 

for inspecting foreign establishments. However, FDASIA eliminated this 

distinction, instead directing FDA to take a risk-based approach to 

inspecting both domestic and foreign drug manufacturing establishments, 

consistent with a recommendation we made to FDA in 2008.21

To prioritize establishments for surveillance inspections, CDER applies its 

risk-based site selection model to its catalog of establishments each year 

to identify those establishments (both domestic and foreign) that, based 

on the characteristics of the drugs being manufactured, pose the greatest 

potential public health risk should they experience a manufacturing 

defect. This model analyzes three major factors—facility score, product 

score, and time since last inspection—to develop a list of establishments 

that FDA considers to be a priority for inspection.22 Establishments may 

also be selected for surveillance inspections for other reasons, such as 

FDA’s focus on a particular product. Through this process, CDER 

develops a priority list of establishments selected for inspection that is 

then ranked and submitted to ORA. To be efficient with its resources, 

ORA staff may shift the order of establishments to be inspected on 

 20In previous reports, we have referred to establishments that FDA identified as subject to 

inspection as an “inventory.” FDA now refers to this compilation as a “catalog,” a term we 

have adopted for the purposes of this report.

21Pub. L. No. 112-144, § 705, 126 Stat. 1066 (codified at 21 U.S.C. 360(h)(4)). For our 

previous recommendation, see GAO-08-970.

22The facility score includes information about the facility and its history, such as the type 

of establishment (for example, a manufacturer or a laboratory), number of products 

produced at the facility, and inspection history. The product score, meanwhile, captures 

information about a product itself, such as its therapeutic category (for example, an antifungal), its dosage form, and whether it is sterile.
Page 10 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

CDER’s prioritized list based on geographic proximity to other planned 

inspection trips.

FDA opened its foreign offices in 2008 to engage with foreign 

stakeholders to develop information that FDA officials can use to make 

better decisions about products manufactured in foreign countries for the 

U.S. market. To accomplish this, the foreign offices focus on the following 

activities:

1. establishing relationships with U.S. agencies located overseas and 

foreign stakeholders, including regulatory counterparts and industry, 

to facilitate collaborations that will streamline and enhance global drug 

development and regulation;

2. gathering better information locally on product manufacturing and 

transport to U.S. ports;

3. expanding FDA’s inspectional capacity to include inspections of FDAregulated commodities, such as drugs, medical devices, and food 

products, conducted by investigators based in the foreign offices; and

4. providing assistance to strengthen the regulatory systems of FDA’s 

foreign counterparts to better assure the safety of the products 

manufactured and exported from their countries to the United 

States.23

Currently, FDA has foreign offices in China, Europe, India, and Latin 

America. Some offices have more than one office location, also known as 

a post.24 (See fig. 1.) FDA previously had foreign offices located in Africa 

and the Middle East, but these offices have since closed and been 

consolidated under the Office of Regional and Country Affairs, an OIP 

 23FDA’s capacity building, also known as technical cooperation, includes the provision of 

scientific, technical, regulatory, or inspection assistance, and education and training to 

help strengthen public health regulatory infrastructures abroad, especially for countries 

where exports to the United States are significant or increasing. FDA also engages with 

foreign industry to help assure their understanding of U.S. standards.

24Specifically, the Latin America office has posts in Santiago, Chile; San Jose, Costa Rica; 

and Mexico City, Mexico. The Europe office has posts in Brussels, Belgium, and London, 

United Kingdom, and previously had a post in Parma, Italy that closed in 2012. Although 

the China office currently has one post in Beijing, it previously had posts in Guangzhou 

and Shanghai, which closed in 2014. Similarly, the India office currently has one post in 

New Delhi, but it previously had a post in Mumbai that closed in July 2016.

FDA’s Foreign Offices
Page 11 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

office based domestically in FDA’s headquarters.25 For fiscal year 2016, 

FDA budgeted approximately $35.2 million for the China, Europe, India, 

and Latin America offices, an increase over the $29.9 million budgeted for 

them in fiscal year 2009.26

 25Specifically, FDA previously had foreign offices in Amman, Jordan, and Pretoria, South 

Africa, which closed in 2013 and 2015, respectively. Currently, the Office of Regional and 

Country Affairs manages FDA’s activities in Asia and the Pacific (with the exceptions of 

India and China), the Middle East, Africa, and Canada. The office is responsible for 

fostering collaboration and the sharing of information and technical expertise with 

counterpart regulatory authorities throughout the regions, both directly and through their 

embassies in Washington, D.C. For the purposes of this report, we do not include this 

office when we refer to FDA’s “foreign offices” since the office and its staff are based in 

the United States.

26The $29.9 million budgeted for the foreign offices in fiscal year 2009 included some 

posts for the China and India offices that have since closed. All staffing and administrative 

costs associated with the offices are included in budgeted amounts. 
Page 12 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Figure 1: Geographic Responsibilities of the Food and Drug Administration’s (FDA) Foreign Offices, Including Their 

Locations, as of October 2016

Note: The Latin America office encompasses three office locations, also known as posts, in Mexico 

City, Mexico; San Jose, Costa Rica; and Santiago, Chile. The Europe office includes two posts in 

London, United Kingdom, and Brussels, Belgium. FDA’s Office of International Programs (OIP) also 

has a domestic office that covers other regions in the world. Specifically, OIP’s Office of Regional and 

Country Affairs is responsible for agency interactions in other areas of the world, such as Canada, 

Australia, and the Middle East, which are not covered by one of FDA’s foreign offices.

As of July 2016, FDA had 29 staff members assigned to work in the 

foreign offices, including a director and deputy director in each office. The 

offices also have international program and policy analysts who analyze 

the impact of foreign issues on FDA programs and activities, and other 

staff who are responsible for engaging with foreign stakeholders and 
Page 13 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

gathering information. There are also investigators who conduct 

inspections of establishments manufacturing food or medical products in 

the China, India, and Latin America offices.27 The offices also have locally 

employed staff, who are non-U.S. citizens employed by the FDA foreign 

offices.28 Finally, OIP staff based in its domestic offices assist the foreign 

offices in addition to performing other duties related to advancing FDA’s 

global mission.

FDA foreign office staff are posted overseas for two-year assignments. In 

addition, FDA may send staff to the foreign offices to perform temporary 

duty assignments of up to 120 days. HHS policy requires that its overseas 

staff commit to assignments of no more than 2 years per tour; however, 

staff have the option to renew in increments of one or two years, for up to 

a total of 6 years in one country, subject to strategic goals and

management concurrence on performance. Staff can then rotate to a new 

country, but HHS requires that staff spend no more than 12 consecutive 

years overseas before returning to the United States for at least 1 year.

Since fiscal year 2009, FDA has increased the number of all foreign drug 

inspections conducted each year. Additionally, the agency has taken 

steps to improve the accuracy and completeness of its catalog of foreign 

drug establishments, although FDA still lacks inspection history for 33 

percent of this catalog. FDA has also strengthened the management of its 

process for prioritizing drug establishments for surveillance inspection, in 

particular its risk-based site selection model.

 27These investigators come from ORA, but are assigned to OIP for the duration of their 

terms abroad. While stationed overseas, FDA investigators are considered to be 

consumer safety officers. For purposes of this report, we refer to these staff throughout as 

investigators. 

28Locally employed staff are hired to work in the foreign offices to work on administrative 

issues or provide technical expertise as needed. As of July 2016, there were 19 locally 

employed staff located in the Europe, China, India, and Latin America offices. Adding 

these staff to the 29 FDA staff assigned to the foreign offices brings the total number of 

staff working in FDA’s foreign offices to 48. 

FDA Has Increased 

Its Foreign Drug 

Inspections and 

Enhanced Its Ability 

to Prioritize Drug 

Establishments for 

Inspection
Page 14 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA has consistently increased the total number of foreign drug 

inspections—which include surveillance, preapproval, and for-cause 

inspections—conducted each year since fiscal year 2009, as shown in 

figure 2.29 This is consistent with a recommendation we made in 2008, 

when we recommended that FDA conduct more inspections to ensure 

that foreign drug establishments are inspected at a frequency comparable 

to domestic establishments with similar characteristics.30 Beginning in 

fiscal year 2015, FDA conducted more foreign than domestic inspections.

 29We are using the number of foreign drug inspections conducted in a fiscal year in our 

calculations, rather than the number of unique foreign drug establishments inspected. 

Although FDA can inspect an establishment more than once a year, during this time 

period there was not a sizeable difference between the number of foreign inspections 

conducted and the number of unique establishments inspected.

30See GAO-08-970. 

FDA Has Increased the

Number of Foreign Drug 

Inspections Since Fiscal 

Year 2009
Page 15 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Figure 2: Total Number of Food and Drug Administration (FDA) Inspections of Domestic and Foreign Drug Establishments, 

Fiscal Year 2007 through June 30, 2016

Note: This figure shows the number of foreign drug inspections conducted in a fiscal year, rather than 

the number of unique foreign drug establishments inspected. Although FDA can inspect an 

establishment more than once a year, during this time period there was not a sizeable difference 

between the number of foreign inspections conducted and the number of unique establishments 

inspected.

According to FDA officials, the agency has leveraged multiple staff 

resources to enable it to increase the number of foreign drug inspections 

conducted by the agency in recent years.

• ORA investigators based in FDA’s domestic district offices continue to 

represent the majority of people participating in FDA’s foreign 

inspections (approximately 49 percent of the total number of 

inspections conducted).

• As we previously reported, though, FDA established a dedicated 

foreign drug cadre in January 2009. The group of 15 domestically 
Page 16 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

based ORA staff exclusively participate in foreign drug inspections.31

FDA told us that the agency increased the number of staff assigned to 

the foreign cadre to 20 in 2012. Currently, the foreign cadre 

represents the next highest percent of staff participating in foreign 

inspections (approximately 31 percent of total inspections).

• Additionally, the Generic Drug User Fee Amendments Act (GDUFA) 

of 2012 authorized FDA to collect user fees from manufacturers of 

generic drugs, providing the resources to hire 80 additional 

investigators focused on inspecting generic drug manufacturers.32

FDA officials said that these investigators have primarily been 

assigned to foreign inspections, but during the period we reviewed, 

they participated in a relatively small percentage of the total number of 

foreign drug inspections conducted (approximately 8 percent of 

inspections).

33

• Investigators assigned full-time to FDA’s foreign offices have also 

participated in inspections of foreign drug establishments 

(approximately 5 percent of inspections).

• Since fiscal year 2012, the foreign offices have also made use of 

temporary duty assignments from ORA to assist the foreign offices in 

completing their work priorities, including inspections. Staff on 

temporary duty assignments have participated in approximately 2 

percent of foreign drug inspections.

• In addition, there are a variety of other FDA staff who, on occasion, 

may participate in an inspection if certain subject matter expertise is

needed.

In addition to using various FDA staff to conduct foreign inspections, the 

agency has increased funding dedicated to conducting foreign 

inspections. According to FDA officials, the agency obligated 

approximately $53 million to foreign inspections in fiscal year 2010. This 

amount has increased each year since, to $92 million in fiscal year 

 31See GAO-10-961. 

32Pub. L. No. 112-144, tit. III, 126 Stat. 1008 (codified in pertinent part at 21 U.S.C. § 379j42).

33The relatively low number of inspections conducted by the additional investigators hired 

using funds made available by GDUFA fees could be due to the fact that they only began 

conducting inspections in fiscal year 2014, when they participated in 3 inspections. The 

majority of their drug inspections occurred in fiscal years 2015 and 2016, when they 

participated in 172 and 179 inspections, respectively.
Page 17 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

2015.34 The average cost of a foreign drug inspection has slightly 

decreased over the years. FDA had estimated that the average cost of a 

foreign inspection was between $60,000 and $62,500 for fiscal year 2009; 

for fiscal year 2015, the average cost was $57,600. 

The locations where FDA has conducted foreign inspections have largely 

remained the same from what we previously reported. Specifically, FDA 

conducted drug inspections in 68 total countries from fiscal year 2010 and 

June 30, 2016, with 76 percent of these inspections conducted in 10 

countries. Establishments in India were the most frequently inspected, 

followed by ones in China and Germany. (See table 1.) This mirrors what 

we previously found in 2010.35

 34The agency has also increased its funding dedicated to conducting domestic 

inspections. According to FDA, the agency obligated approximately $115 million in fiscal 

year 2010 for domestic drug inspections and increased the amount each year to 

eventually $152 million in fiscal year 2015.

35In 2010, we found that the 10 most frequently inspected countries were (1) India, (2) 

China, (3) Germany, (4) Canada, (5) United Kingdom, (6) Italy, (7) France, (8) Japan, (9) 

Ireland, and (10) Switzerland, followed by all other countries.
Page 18 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Table 1: Total Number of Food and Drug Administration (FDA) Drug Inspections of Foreign Establishments, by Country, 

Fiscal Year (FY) 2010 through June 30, 2016

Country FY 

2010

FY 

2011

FY 

2012

FY 

2013

FY 

2014

FY 

2015

FY 2016 

through 

June 30, 2016

Total Estimated number of foreign 

establishments subject to surveillance 

inspection as of June 2016a

India 72 99 140 110 114 204 101 840 572

China 48 89 59 74 113 129 81 593 535

Germany 50 35 59 60 72 68 37 381 191

Canada 24 43 49 51 39 52 30 288 166

Italy 33 36 38 45 50 41 34 277 146

Japan 23 22 49 28 47 31 39 239 162

France 32 24 25 36 44 45 22 228 146

United 

Kingdom

16 31 29 27 33 43 18 197 136

Switzerland 26 30 23 23 37 31 16 186 89

Ireland 12 17 14 21 26 17 14 121 60

All other 

countries

104 133 140 161 204 181 111 1,034 820

Total 440 559 625 636 779 842 503 4,384 3,023

Source: GAO analysis of FDA data. | GAO-17-143

a

The counts in this column represent the estimated number of foreign drug establishments that FDA 

will use for the fiscal year 2017 risk-based site selection model. FDA does not keep historical records 

reflecting the number of establishments subject to inspection each year. Agency officials told us they 

do not keep such records as the number of establishments subject to inspection frequently fluctuates 

as establishments begin, stop, or resume marketing products in the United States. As a result, we 

could not determine the estimated number of foreign establishments that were subject to inspection 

for fiscal year 2010 through fiscal year 2016.

Since 2009, FDA has changed the types of inspections it primarily 

conducts at foreign drug establishments. Specifically, more than half (55 

percent) of all foreign inspections conducted from fiscal year 2010 

through June 30, 2016, were surveillance-only inspections rather than 

preapproval inspections. (See fig. 3.) This is a significant increase since 

fiscal year 2009, when we found that 17 percent of foreign inspections 

were surveillance inspections, with the vast majority conducted in 

response to an application to market a new drug in the United States.36

FDA officials acknowledged that foreign inspection priorities had 

previously been driven by pending applications for new drugs. However, 

 36See GAO-10-961. For fiscal year 2009, we found that the majority of foreign drug 

inspections FDA conducted contained both a preapproval and surveillance component (74 

percent), followed by surveillance-only (17 percent), then preapproval only (9 percent).
Page 19 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

this was prior to the enactment of FDASIA, when FDA was required to 

inspect all domestic establishments every 2 years, and also before an 

increase in funding available for foreign inspections provided for by 

generic drug user fees. FDA officials also said the agency eliminated a 

policy whereby inspections conducted for preapproval purposes often 

drove the selection of foreign establishments for inspections. As a result, 

FDA officials said that the selection of foreign establishments for routine 

surveillance inspections is now entirely driven by the risk-based site 

selection model. (See app. I for information on the number and types of 

foreign drug inspections conducted from fiscal year 2010 through June 

30, 2016.)

Figure 3: Food and Drug Administration (FDA) Inspections of Foreign Drug 

Establishments by Type of Inspection, Fiscal Year 2010 through June 30, 2016

a

This category includes any inspection that included a “for-cause” component. For-cause inspections 

are conducted to investigate consumer complaints, reports of product quality defects submitted by 

consumers or health care professionals, or indications of potential manufacturing problems submitted 

by the manufacturers themselves, among other reasons.
Page 20 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Since 2010, FDA has taken steps to improve the accuracy and 

completeness of its catalog of foreign drug establishments. These steps 

are intended to address what FDA acknowledged as a challenge as early 

as 1988, following an internal evaluation that recommended that the 

agency develop a comprehensive catalog of all foreign establishments 

shipping drugs to the United States that could be used to improve longrange inspection planning and scheduling.37 We also highlighted this 

challenge in our previous reports.38 Most recently, in 2010, we found that 

a majority (64 percent) of foreign establishments in FDA’s catalog may 

never have been inspected by the agency. Since then, FDA officials said 

that the agency has taken steps to improve the accuracy and 

completeness of its catalog by

• Requiring establishments to use a unique, numeric identifier. FDASIA 

required establishments to provide a unique facility identifier during 

their annual registration with FDA, and FDA elected to require 

establishments to use the Dun and Bradstreet Data Universal 

Numbering System (D-U-N-S®) number.39 Using this number allows 

FDA to automatically validate data from every registration submission 

against the Dun and Bradstreet database to ensure the accuracy of 

the information. Any mismatch may result in rejection of a registration 

submission. The D-U-N-S® number also allows FDA to determine 

whether a firm has gone out of business or relocated. FDA officials 

said that it has also helped FDA improve the interoperability of the 

agency’s data systems that collect or use registered facility 

information, as well as the interoperability of other agencies’ systems.

• Adding two foreign inventory coordinators in 2013 tasked with 

incorporating foreign registrations and annual updates into FDA’s 

master inventory. Additionally, these coordinators are responsible for 

updating FDA’s inspection data to reflect accurate inventory updates.

• Establishing a data governance board to define standards, best 

practices, and policies for inventory data management. According to 

FDA officials, the governance board, which was created in May 2015, 

meets biweekly to examine the databases responsible for storing 

 37Office of Regulatory Affairs, Program Evaluation Branch, “An Evaluation of FDA’s 

Foreign Inspection Program,” Rockville, Md., March 1988. This internal evaluation found 

that FDA did not maintain a catalog (previously referred to by FDA as an inventory) of all 

foreign drug establishments that were subject to FDA regulation.

38See GAO/HEHS-98-21; GAO-08-970; and GAO-10-961. 

39Pub. L. No. 112-144, § 702(b), 126 Stat. 1065 (codified at 21 U.S.C. § 360(i). 

FDA Has Improved 

Information on Its Catalog 

of Foreign Drug 

Establishments, but Lacks 

Inspection History on OneThird of Them
Page 21 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

information about drug establishments. Officials said the board has 

developed guidance for merging data processes and is working 

toward defining data metrics to determine whether they have 

improved on their reporting. The board has also defined data 

standards for storing key attributes of establishments, such as 

companies’ names, and continues to examine best practices for 

sharing establishment data across FDA.

As a result of these steps, FDA has reduced its catalog of establishments 

that may never have had a surveillance inspection. Currently, FDA lacks 

information on the inspection history of 33 percent of the foreign 

establishments in its catalog, compared to the 64 percent for which it 

lacked inspection history in 2010. According to FDA officials, the 

establishments that are subject to inspections are continuously changing. 

For example, they said that some of the establishments without an 

inspection history may be newly registered with the agency, thus 

accounting for their lack of an inspection history; others could be 

establishments that are not subject to inspection, such as those that may 

have gone out of business or that have never shipped products to the 

United States. Although this may be the case for some—or even many—

of these establishments, the fact remains that FDA does not know 

whether or for how long these establishments have or may have supplied 

drugs to the U.S. market, and has little other information about them. 

While the agency has made progress in reducing this knowledge gap, it is 

important to note that the overall number of foreign establishments with 

no surveillance inspection history (about 1,000 of the approximately 

3,000) remains large.40 (See app. II for information on the numbers and 

locations of the establishments for which FDA lacks an inspection 

history.)

To address this persistent concern, the agency plans to inspect all 

establishments in its catalog with no prior surveillance inspection history 

over the next 3 years (approximately one-third each year), beginning in 

fiscal year 2017. FDA will consider these establishments’ risk scores as 

determined by the agency’s risk-based site selection model to prioritize 

them for inspection, starting with those establishments having the highest 

risk scores. Some recent FDA inspections have uncovered significant 

issues at foreign drug manufacturing establishments, including raw 

material storage rooms that had never been cleaned and the presence of 

 40The majority of these establishments are in China, India, and South Korea.
Page 22 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

pests in a controlled processing area, underscoring the importance for 

FDA to fill this knowledge gap.

FDA has strengthened the management of its process for selecting drug 

establishments (domestic and foreign) for surveillance inspection. First, 

FDA generated a combined list of foreign and domestic establishments 

for use with the fiscal year 2016 risk-based sited selection model. Using a 

combined list of establishments with the risk-based site selection model 

reflects the agency’s full implementation of the 2012 FDASIA provision 

that directed FDA to take a risk-based approach to inspecting both foreign 

and domestic establishments. This is also consistent with a 

recommendation we made to the agency in 2008.41 For fiscal year 2016 

and beyond, FDA officials said that ORA will only select establishments 

for surveillance inspection from the combined prioritized list—beginning 

with those establishments with the highest risk score, regardless of 

whether they are foreign or domestic—until they have exhausted their 

surveillance inspection capacity for that year. Prior to fiscal year 2016, 

foreign and domestic establishments were selected for inspection from 

separate prioritized lists, and in different manners.42 As a result, during 

this time, FDA officials said that a one-for-one match between the lists of 

foreign establishments prioritized for inspection and the final list of actual 

inspections conducted would be unlikely. Officials said that the prioritized 

lists of foreign establishments for fiscal year 2010 through fiscal year 

2015 provided a framework for planning surveillance inspections, but that 

ORA was given discretion as to which specific establishments from the 

priority list would be inspected each year. Collectively, FDA officials said 

that the results from the priority list, the needs of the centers, and any 

unforeseen events dictated the final list of foreign establishments 

 41See GAO-08-970.

42Specifically, FDA officials said that investigators were required to first inspect domestic 

facilities with risk scores above a certain threshold (but allowing for substitutions as 

needed), before inspecting remaining domestic establishments. In comparison, according 

to FDA officials, inspecting foreign establishments with the highest risk scores was not a 

requirement; rather, ORA was given discretion in selecting foreign establishments from 

the priority list to account for logistical challenges associated with planning foreign 

inspection trips.

FDA Has Strengthened 

the Management of Its 

Risk-Based Site Selection 

Model
Page 23 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

inspected prior to fiscal year 2016, and the final list could differ from the 

priority list generated by the risk-based site selection model.43

Second, in 2015, the agency formalized its process for selecting 

establishments for inspection according to an establishment’s known 

safety risks, based on certain risk factors specified by FDASIA. These 

factors are an establishment’s compliance history, recall history, inherent 

product risk, inspection frequency and history, and whether the 

establishment has been inspected by a foreign government or agency.44

FDA officials said that the agency has long considered certain FDASIA 

factors in selecting establishments to inspect, such as an establishment’s 

inspection history. However, its risk-based site selection model has 

become increasingly sophisticated in factoring in specific details about 

establishments, the products they make, and other elements into the site 

selection process. Officials acknowledged that FDA cannot yet 

systematically determine whether an establishment has been subject to 

inspection by a foreign government or agency, because this requires the 

agency to negotiate agreements with foreign regulators to obtain 

meaningful foreign inspection results. Officials stated that FDA is in the 

process of doing so. However, FDA has been working on pursuing such 

agreements and determining how they may help the agency to assess the 

risk of foreign establishments when prioritizing them for almost a 

decade.45 As they continue to explore these agreements, FDA officials 

said the agency does, on a case-by-case basis, review and exchange 

information with certain foreign regulators, which may result in the agency 

re-prioritizing its inspection schedule to address emergent issues.

Third, in fiscal year 2017, FDA plans for the first time to allow no more 

than 5 years to elapse between surveillance inspections at a specific 

establishment. That is, if an establishment included in FDA’s catalog of 

 43FDA officials explained that, at the beginning of each year, ORA would engage with the 

centers to discuss inspection priorities for the upcoming year. ORA would then consider its 

available resources before proceeding with inspections. In addition, unplanned events, 

such as a natural disaster, could affect the total number of inspections that could be 

conducted in a given year. 

44FDASIA also authorizes the Secretary of Health and Human Services to consider 

additional criteria deemed necessary and appropriate. Pub. L. No. 112-144, § 705,126 

Stat. 1066 (codified at 21 U.S.C. § 360(h)(4)).

45GAO, Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, 

but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program,

GAO-08-701T (Washington, D.C.: Apr. 22, 2008).
Page 24 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

establishments subject to inspection has not been inspected in 4 years, 

the establishment is automatically included on the inspection list for the 

fifth year. According to FDA officials, the agency previously did not 

include a “hard stop” of a predetermined time in its model. For fiscal year 

2017, after FDA inspects one-third of the establishments with no 

inspection history the agency will prioritize for inspection these 

establishments that have not had a surveillance inspection within the past 

5 years. Once these inspections are completed, FDA plans to inspect 

establishments that were prioritized by the risk-based site selection model 

through its annual process. Should FDA complete inspections of all of the 

establishments prioritized through the risk-based site selection model, the 

agency plans to conduct additional inspections of as many of the 

remaining two-thirds of establishments with no inspection history as 

possible, given remaining inspection resources.

Fourth, FDA recently formalized its process for developing, evaluating, 

and documenting key decisions about its model each year. Prior to this 

effort, FDA lacked a formal approach to evaluating its model and 

documenting key decisions. As a result, in some cases, FDA was unable 

to recall or explain how the model—or the process to update it—had 

changed over time. Officials said that our prior reviews reinforced the 

need for a written procedure and a formal governance structure to 

support the development of the risk-based site selection model. In fiscal 

year 2016, FDA instituted a formalized process for developing and 

evaluating its fiscal year 2017 model and documenting key decisions 

made as a result of this evaluation. As part of this process, FDA created a 

review board that features multiple levels of input of the model’s design 

from FDA experts and senior management, and in October 2016 finalized 

a document that outlines roles and responsibilities related to the model, 

and that indicates how it is to be annually updated and implemented. FDA 

also incorporated best practices learned from its first experience using the

review board to guide the development of the model. Officials said the 

document, going forward, will chronicle the decisions officials make 

regarding which factors were included in the model for a particular year 

and why. FDA’s formalized process for evaluating and updating its riskbased site selection model may improve the agency’s ability to monitor 

whether establishments that pose the greatest risk to public health, were 

they not to comply with CGMPs, are being selected for inspection. FDA is 

performing monitoring activities through its formalized process by 

annually updating the factors and weights included in the model through 

its newly formalized governance structure. This process allows subject 

matter experts to provide input each year on the relative importance of 

each factor and whether the factor should be included in the model.
Page 25 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA has begun to take steps to enhance the agency’s strategic planning 

for the foreign offices and has developed two performance measures. 

However, FDA could not readily cite the effectiveness of the offices’

contributions, which began opening in 2008. High vacancy rates in the 

foreign offices threaten to impede the offices’ efforts to ensure drug 

safety.

FDA has made progress in its strategic planning efforts for its foreign 

offices since we last reported on them in 2010. For example, FDA has 

standardized how the foreign offices relay information about their 

activities. Specifically, each foreign office now completes an annual 

operational plan—updated quarterly—to ensure their activities are 

consistently reported and to facilitate tracking the outcomes of their 

efforts. Foreign office officials said that they worked closely together to 

align the core activities listed in the operational plans with OIP’s strategic 

goals to improve officials’ understanding of how each foreign office 

contributes to fulfilling OIP’s mission of helping protect public health. For 

example, the plans include examples of activities related to data 

gathering, analysis, and information sharing, which support one of OIP’s 

strategic goals of collecting and sharing intelligence and information. 

Officials said they use the operational plans to track whether the foreign 

offices’ annual accomplishments are fulfilling OIP’s goals, and noted that 

having a common operational plan across the offices allows for a 

common language amongst officials when discussing their efforts.

In addition, FDA officials noted they have taken the step of convening the 

foreign office directors and deputy directors at FDA headquarters at least 

once a year since 2010 to discuss their ongoing efforts and exchange 

best practices with each other, with the most recent convening occurring 

in April 2016. FDA officials also said that communication between the 

foreign offices and other FDA offices, including CDER and ORA, has 

increased over the years. For example, officials told us that OIP 

management and the foreign office directors and deputy directors have 

been meeting three times per month to ensure that the foreign offices are 

obtaining the types of information that would be most helpful in ensuring 

the safety of drugs entering the United States.

FDA Has Not Yet 

Assessed Its Foreign 

Offices’ Contributions 

to Drug Safety, and 

Their Efforts are 

Impeded by High 

Vacancy Rates

FDA Has Made Progress 

in Strategic Planning for 

Its Foreign Offices
Page 26 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA has begun to take steps in response to two recommendations we 

previously made to enhance the agency’s strategic planning for the 

foreign offices. Specifically, we recommended in 2010 that FDA develop 

(1) performance goals and measures that can be used to demonstrate the 

offices’ contributions to long-term outcomes related to imported FDAregulated products; and (2) a strategic workforce plan for the foreign 

offices to help ensure that the agency is able to recruit and retain staff 

with the experience and skills necessary for the foreign offices, and to 

reintegrate returning staff from overseas into FDA’s domestic offices.46

Since then, OIP has developed two performance measures with 

established targets—number of inspections conducted by full-time 

medical product investigators at foreign offices and number of 

collaborative actions by OIP—that are used to assess the foreign offices’ 

contributions.47 According to FDA, the agency met its collective targets for 

these measures for fiscal year 2015.

First, regarding the number of inspections by foreign office staff, FDA set 

a performance measure in fiscal year 2016 for full-time medical product 

investigators assigned to the China, India, and Latin America offices for 

each to conduct 15 medical product inspections.48 In other words, if there 

were two medical product investigators assigned to the China office, their 

target for the year would be 30 medical product inspections. Moreover, 

according to FDA, this goal applies to not only drugs, but all FDA medical

product inspections, including medical devices and bioresearch 

monitoring inspections. There is not a specific “drug inspection”

performance measure, although in practice, foreign office investigators 

are assigned a specific commodity (for example, food, drugs, or medical 

devices) to inspect. Depending on the current staffing composition,

foreign office investigators could meet their target of 15 medical product 

inspections by inspecting establishments manufacturing medical products 

other than drugs.

Although FDA opened foreign offices abroad, in part, to help improve 

FDA’s capacity to conduct foreign inspections, the staff in those offices 

 46See GAO-10-960. 

47FDA defines a collaborative action as concrete regulatory and public health actions, or 

initiatives that contribute toward supporting OIP objectives and outcomes.

48The Europe office does not have investigators assigned to its office, although officials 

said it has assisted with planning for foreign drug inspections that are conducted by 

investigators based in the United States.

Since 2010, FDA Has 

Developed Two 

Performance Measures, 

but They Do Not 

Meaningfully Assess the 

Foreign Offices’ 

Contributions to Drug 

Safety
Page 27 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

have conducted relatively few drug inspections since fiscal year 2010. 

Specifically, of the total number of drug inspections conducted between 

fiscal year 2010 and June 30, 2016 (4,384), investigators assigned fulltime to the foreign offices participated in 241 (5 percent) of these 

inspections. The total number of drug inspections conducted each year by 

these full-time investigators ranged from 29 to 52, with the India office 

investigators conducting about two-thirds of the total number of 

inspections. See table 2 for more information on the number of drug 

inspections conducted by the foreign offices in India, China, and Latin 

America.

Table 2: Total Number of Food and Drug Administration (FDA) Drug Inspections in which Foreign Office Investigators

Participated, Fiscal Year (FY) 2010 through June 30, 2016

FDA Foreign Office FY 2010 FY 2011 FY 2012 FY 2013 FY 2014a FY 2015 FY 2016 

through 

June 30, 

2016

Total

India office 25 20 28 38 24 17 9 161

China office 8 11 1 11 2 9 15 57

Latin America office 0 0 0 3 4 11 5 23

Total 33 31 29 52 30 37 29 241a

Source: GAO analysis of FDA data. | GAO-17-143

a

Between fiscal year 2010 and June 30, 2016, FDA conducted a total of 4,384 foreign drug 

inspections. Foreign office investigators participated in 241 (5 percent) of these inspections.

We previously reported in 2010 that FDA did not have a goal for how 

many inspections it would like foreign office investigators to conduct—

although this has since changed with its inspection targets—but that the 

agency would like to see overall increases in the number of inspections 

conducted in both China and India.49 However, in the case of drug 

inspections, this goal has not yet been fully realized, as the number of 

inspections conducted by the India office has decreased since fiscal year 

2013 and the number of inspections conducted by the China office has 

only just reached a new high in fiscal year 2016. We understand and 

previously reported that the China office had difficulty in obtaining visas 

from the Chinese government for its staff to deploy overseas for several 

years, which may have contributed to the low number of inspections 

conducted by the office during these years.50 FDA appears to have been 

 49See GAO-10-960. 

50See GAO-15-183. 
Page 28 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

able to overcome this particular challenge in 2014, and FDA officials told 

us there has been an overall increase in the total number of authorized 

foreign office staff who can perform foreign inspections since we reported 

in 2010. Specifically, in 2010 there were four investigators in the China 

office and three in the India office. As of July 2016, there were 11 of 18 

authorized investigators in China, 3 of 13 authorized investigators in 

India, and 1 of 2 authorized investigators in the Latin America office, 

although these additional investigators may be conducting inspections of 

establishments that manufacture other FDA-regulated products, such as 

food. For example, according to FDA, in fiscal year 2015, foreign office 

investigators conducted 150 inspections of food establishments; 79 

medical product inspections; and 8 veterinary medicine inspections; for a 

total of 237 inspections.51 FDA has also authorized 18 additional 

investigators for its foreign offices that the agency has yet to fill and of 

which at least 9 are intended to be assigned to performing drug 

inspections.

Drug inspections may also be conducted by temporary duty staff who are 

deployed to the foreign offices for 30-, 60-, 90-, or 120-day assignments 

to, in part, supplement the number of inspections conducted by the 

foreign offices. From fiscal year 2012, when staff began serving 

temporary duty in the foreign offices, through June 30, 2016, these staff 

participated in an additional 105 foreign drug inspections—bringing the 

total number of inspections in which full-time and temporary foreign office 

staff participated to 346. (For more information on the number of foreign 

drug inspections temporary duty staff have performed by year, see app. 

III.)

Regarding the second measure, collaborative actions, FDA set a target of 

completing 25 such actions for all of OIP for fiscal year 2016, according to 

FDA officials. The outcomes of this measure have been tracked internally 

by OIP since fiscal year 2014, when the measure was first implemented. 

OIP officials told us they use specific criteria to determine whether an 

activity qualifies as a collaborative action. For example, activities qualify 

only if they include collaboration with an external stakeholder or U.S. 

government agency other than FDA. Similarly, inspections conducted by 

foreign office investigators are excluded (as these are tracked separately) 

unless a foreign regulatory counterpart participates in the inspection with 

 51Of the 237 inspections completed by foreign office investigators in fiscal year 2015, 148 

involved full-time foreign office investigators and 89 involved investigators on temporary 

assignment to the foreign offices.
Page 29 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA staff. In addition, activities are excluded if no tangible deliverable or 

result was identified. FDA reported exceeding its goal of 25 collaborative 

actions in fiscal year 2015 by 2, for a total of 27 collaborative actions.

We identified shortcomings with using the collaborative action measure to 

assess the foreign offices’ performances. First, the measure and its target 

are not unique to the foreign offices. According to FDA officials, this 

measure applies to all of OIP’s offices—both foreign and domestic. When 

asked about its decision to expand this target to all of OIP, rather than 

specifically focusing on the foreign offices, officials said that they prefer to 

adopt a holistic approach to assessing OIP’s contributions. However, in 

adopting this approach, the measure does not reflect the unique 

contributions of the foreign offices as they are not distinguished from 

those made by OIP as a whole. Second, the target of 25 collaborative 

actions for all OIP does not necessarily target actions that are specific to 

drug safety-related efforts. FDA officials said the efforts could be focused 

on any commodity regulated by FDA, such as food and medical devices, 

meaning that the target could potentially be met without performing a 

single activity related to enhancing drug safety. Third, the measure is not 

expressed in terms of an end outcome. End outcomes are the results of 

programs and activities compared to their intended purpose.52 In this 

case, FDA’s collaborative action measure is not expressed in terms of the 

foreign offices’ purpose of enhancing drug safety. Furthermore, FDA 

officials—those in the foreign offices who engage in collaborative actions 

and those at FDA headquarters—acknowledge that it can be difficult to 

link the results of a foreign office’s actions to enhanced drug safety.

Beyond the shortcomings of the collaborative action measure, FDA could 

not readily cite the overall effectiveness of the offices’ contributions, and it 

has not completed a thorough assessment of their accomplishments,

despite the implementation of the two performance measures within the 

last six years. Standards for internal control in the federal government call 

for agencies to have control activities that are designed appropriately to 

(1) conduct top-level reviews of actual performance, (2) review activities 

at the activity level, and (3) review performance measures and 

indicators.53 While the foreign office staff may be engaged in meaningful 

 52See GAO, Managing for Results: EPA Faces Challenges in Developing ResultsOriented Performance Goals and Measures, GAO/RCED-00-77 (Washington, D.C.: Apr. 

28, 2000). 

53See GAO-14-704G.
Page 30 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

activities, the activities cannot be systematically tracked by FDA using the 

two performance measures currently in place nor, according to officials, 

does the agency have a process in place to formally assess the offices’

contributions. For example, FDA has not systematically tracked how 

information obtained from the foreign offices, and subsequently shared 

with FDA’s centers and offices, contributed to increased drug safety, as 

such information would only be tracked if obtained in collaboration with 

foreign stakeholders. Additionally, FDA’s two current performance 

measures do not capture a range of activities specifically undertaken by 

the foreign offices that resulted in drug safety related outcomes. Such 

outcomes could include additional inspections of foreign establishments 

in their host countries, warning letters to manufacturers in violation of 

CGMPs, or import alerts for products that appear in violation of FDA 

regulations. However, we found that the foreign offices were engaging in 

activities that produced potentially positive outcomes. When asked, FDA 

officials provided us with the following examples:

• In 2012, the India office discovered that an Indian establishment had 

manufactured and distributed API from one of its sites without fulfilling 

FDA’s registration requirements. The India office shared this 

information with FDA’s domestic offices and received concurrence to 

conduct an inspection at the firm’s unregistered establishment, along 

with the firm’s establishment that was registered with FDA. 

Inspections at both establishments revealed significant CGMP 

deficiencies. As a result, FDA issued a warning letter to the firm 

emphasizing the deficiencies and criticizing, among other things, its 

lack of oversight. Both establishments are on import alert.

• In 2013, the India office collected intelligence about an Indian 

company manufacturing APIs that had been linked to deaths in 

another country. The company and an affiliate were thought to be 

manufacturing sub-standard and fraudulent APIs, although FDA could 

not corroborate this through its own inspections since the U.S. 

embassy prohibited the agency from doing so due to security 

concerns. However, the India office followed up with the local 

government and obtained information about the company’s 

establishments from the local government inspections. The local 

government in India had found the company not complying with 

CGMPs. As a result of the India office’s intelligence gathering, the 

company and its affiliate were placed on import alert.

(See app. IV for examples of activities from each foreign office that may 

have helped ensure the safety of drugs entering the United States.)
Page 31 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

However, positive examples such as these are not systematically tracked 

as they do not meet FDA’s criteria of what constitutes a collaborative 

action. FDA’s exclusion of activities that may enhance drug safety 

because they must be performed with a foreign counterpart or other U.S. 

government agency, for example, is not adequate as it does not include 

accomplishments made exclusively by foreign office staff, and leaves the 

agency with no reason to track them. While foreign office investigators 

have participated in for-cause inspections, for example, FDA officials said 

there is no tracking of the foreign offices’ actions that led to such 

inspections in the first place. Therefore, if foreign office staff collect and 

share intelligence about an establishment in a host country with 

domestically based FDA staff that results in an action, which spurs a forcause inspection or detaining a product at the border, this contribution is 

not assessed by any performance measure. An internal evaluation 

completed by FDA’s Office of Planning in July 2016 similarly described

the need for the foreign offices to make efforts to measure their benefits 

by recording instances of, for example, shortened recall time, signed 

FDA-relevant treaties, and other outcome measures. Without tracking 

how information collected by the foreign offices has resulted in these 

types of outcomes, FDA does not have reasonable assurance that the 

foreign offices’ activities have helped ensure the safety of drugs entering 

the United States. 

Furthermore, without evidence on the types of outcomes that resulted 

from information collected by the foreign offices, FDA cannot consider 

these outcomes and plan accordingly as the agency continues to test new 

performance measures for the foreign offices. FDA also cannot ensure 

that it has the correct number of staff deployed with the appropriate skills 

to perform such activities and enable the foreign offices to help fulfill 

FDA’s mission overseas. FDA officials explained to us that the foreign 

offices have not existed for very long and that the changes and progress 

they have undergone since opening have been “remarkable.” However, 

the limitations of FDA’s two current performance measures to 

demonstrate such contributions reinforces the need for FDA to continue 

exploring new performance measures that will better assess the 

contributions of the foreign offices. FDA’s July 2016 internal evaluation 

also described the need for OIP to establish performance measures that 

are aligned with selected outcomes for each foreign office, and that are 

tracked on a consistent basis to allow for continuous improvement and 

management oversight. FDA officials said they are considering using five 

other measures to assess the performance of its foreign offices that are 

currently included in the foreign offices’ operational plans. However, these 

measures have not yet been adopted. FDA considered these measures 
Page 32 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

to be in the testing phase for fiscal year 2016, and said it plans to 

evaluate them in fiscal year 2017.

Persistently high vacancy rates in FDA’s foreign offices threaten to 

impede the offices’ efforts to ensure drug safety. Our concerns extend 

back to 2010, when we reported that FDA had experienced challenges in 

staffing some of the foreign offices. For example, at that time, FDA had 2 

vacant staff positions in the Latin America office out of a total of 14 

positions (14 percent), and 4 vacancies in the India office out of a total of 

15 positions (27 percent). In subsequent years, the number of vacancies 

in the foreign offices has increased. We later found that these rates were 

considerably higher—44 percent overall—as of October 2014.54 This high 

vacancy rate has persisted. As of July 2016, the foreign offices were 

authorized to have 54 full-time positions overseas, but 25 of these 

positions (46 percent) were vacant. The India office has the highest 

vacancy rate at 68 percent (13 vacancies), followed by the Latin America 

office at 43 percent (3 vacancies), the Europe office at 33 percent (1 

vacancy), and the China office at 32 percent (8 vacancies). (See fig. 4 for 

an analysis of vacancies by foreign office.)

Figure 4: Filled and Vacant Staff Positions at the Food and Drug Administration’s 

(FDA) Foreign Offices, as of July 2016

Notes: These numbers exclude approved and vacant positions for locally employed staff.

a

This number excludes the Europe office’s staff who are based in the United States.

 54See GAO-15-183.

FDA Continues to 

Experience High Vacancy 

Rates in Its Foreign 

Offices, Limiting Its Ability 

to Ensure Drug Safety
Page 33 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Across all foreign offices, the position with the greatest proportion of 

vacancies is international program policy analysts, who analyze the 

impact of foreign issues on FDA programs and activities (6 of 10 

authorized positions are vacant), followed by investigators, who conduct 

inspections (18 of 33 authorized positions are vacant). (See table 3.)

Table 3: Number of Authorized and Vacant Positions in the Food and Drug Administration’s (FDA) Foreign Offices, by Office 

and Position-Type, as of July 2016 

Director Deputy 

Director

Supervisory

Investigator 

Investigator International 

Program Policy 

Analyst

Total

China Office Authorized 1 1 2 18 3 25

Vacant 0 0 0 7 1 8

India Office Authorized 1 1 1 13 3 19

Vacant 0 0 1 10 2 13

Latin 

America 

Office

Authorized 1 1 0 2 3 7

Vacant 0 0 0 1 2 3

Europe 

Officea Authorized 1 1 0 0 1 3

Vacant 0 0 0 0 1 1

Source: GAO analysis of FDA data. | GAO-17-143

Note: The Europe office has three staff members authorized to work overseas in Belgium and the 

United Kingdom: the director, deputy director, and one international program policy analyst. 

Additionally, the Europe office has two other international program policy analysts and one program 

support specialist assigned to it who are based in the United States.

Given that one of the reasons for opening the foreign offices was to 

conduct inspections, the large number of vacant investigators is 

concerning. FDA officials have stressed that there are significant benefits 

to having investigators stationed overseas. For example, officials noted 

that foreign office investigators can remain at an inspection site longer, if 

necessary, as they are not limited by travel arrangements to return to the 

United States. They can also initiate for-cause inspections more quickly 

than their domestic counterparts, as they are already in country. Former 

foreign office staff that we spoke with noted that the ability of foreign 

office investigators to conduct inspections quickly in response to 

emergencies is a great advantage of having FDA offices overseas. 

Former foreign office staff also said that it was valuable for investigators 

to be able to focus on their host country’s manufacturers, and to better 

understand how they satisfy CGMPs or their difficulties with doing so.
Page 34 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA acknowledged that recruiting and hiring staff for OIP, especially for 

the foreign offices, can be challenging, but that it is critical for achieving 

FDA’s global mission. FDA’s Office of Planning recently proposed a 

process for selecting foreign office locations and determining the correct 

mix of staffing and position types for them. However, the Office of 

Planning’s proposal did not contain suggestions for overcoming high 

vacancy rates in the foreign offices. OIP has yet to implement this 

proposed process. OIP officials based in the United States and in the 

foreign offices cited several factors contributing to the foreign offices’ 

persistently high vacancy rate. Although some of these factors may be 

beyond the agency’s ability to resolve, others are issues we cited in our 

2010 and 2015 reports that continue to challenge FDA.55 Specifically, 

FDA officials said the following factors contribute to FDA’s difficulty in 

filling its full-time positions overseas:

• Length of time to be cleared for deployment: Officials estimated that it 

takes approximately 9 to 12 months to complete the overseas 

deployment process, which includes, among other things, obtaining 

the appropriate security clearance for the employee, as well as 

medical clearances for the employee and any dependents who will be 

accompanying the employee overseas. Former foreign office staff that 

we spoke with confirmed that the deployment process could be quite 

lengthy, and two former staff specifically mentioned experiencing 

challenges navigating the process. We reported on these challenges 

in both 2010 and 2015.56 FDA officials explained that there is little 

they can do to expedite this timeframe given the length of time 

involved to obtain necessary security and medical clearances required 

to work abroad. Furthermore, the process involves other government 

stakeholders, such as the Department of State, which is responsible 

for the medical clearances, limiting FDA’s ability to control the 

deployment timeframe.

• Reintegration into FDA’s domestic offices: Our discussions with 

former foreign office staff who have since returned to FDA’s domestic 

offices or left the agency following their time spent overseas confirm 

that challenges reintegrating into FDA persist. For example, some 

former foreign office staff reported having to find a job in a domestic 

office on their own, or who faced considerable uncertainty about what 

their new role in the agency would be. Several also noted that the 

 55See GAO-10-960 and GAO-15-183.

56See GAO-10-960 and GAO-15-183.
Page 35 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

skills they developed abroad were not being leveraged, and indicated 

that there was no effort by FDA management or OIP to debrief them 

upon their return. For example, a former policy analyst said he 

developed a unique set of skills for working with foreign regulators on 

potential drug safety issues that were no longer being leveraged by 

the agency once he returned to a domestic position. A former 

investigator, meanwhile, said he had developed a unique set of skills 

for determining whether establishments were falsifying their records, 

but it was unclear how he could best share these skills with other 

investigators upon his return to the United States. We reported on 

concerns about such challenges in both 2010 and 2015, and 

recommended in 2010 that FDA develop a strategic workforce plan to, 

in part, help ensure that the agency was able to reintegrate returning 

foreign office staff into FDA’s domestic offices. FDA developed and 

finalized such a plan in 2016, and prior to this implemented a formal 

reintegration policy in 2015. However, FDA officials have not been 

formally debriefing returning foreign office staff. Of the 13 former 

foreign office staff we interviewed, only 3 of them reported being 

debriefed by OIP. When asked why OIP has not debriefed with 

returning foreign office staff, FDA officials said that they are 

developing a formal exit interview process for returning staff to be 

implemented in fiscal year 2017. However, officials also said that the 

offices are still “young and evolving,” despite having been in operation 

for eight years. These challenges may discourage FDA officials from 

applying for a foreign office position and thus contribute to the foreign 

offices’ vacancies.

• Financial concerns: Our discussions with former foreign office staff 

also show that financial concerns with working overseas persist. For 

example, FDA staff posted overseas do not receive locality pay, so 

staff may have a reduction in their purchasing power when they are 

assigned to a foreign office.57 However, staff at certain locations may 

 57Locality pay is a supplement to the rate of basic pay that is provided to federal 

employees within given localities in the continental United States to offset any gap 

between federal and nonfederal salaries. We previously reported that FDA officials said 

that HHS was considering locality pay to overseas staff. When asked for an update on this 

effort, FDA officials said HHS is still in the process of examining whether to do so. 

Notwithstanding the possibility that certain compensation adjustments and subsidies may 

be made for their benefit, the fact that FDA overseas employees do not receive locality 

pay increases concerns for individuals considering overseas employment.
Page 36 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

receive hardship pay, a cost of living adjustment, and other benefits.58

We reported on this challenge in 2010.59 Additionally, staff may 

experience an increase in pay when they move overseas and may 

receive a promotion while abroad, but such pay increases and 

promotions are considered temporary and staff must return to their 

original salaries and roles when they return to the United States. 

Some former foreign office staff said that these temporary promotions 

were disincentives to working overseas. When asked about this issue, 

FDA officials said they are considering how the agency might be able 

to make the promotions permanent by taking into account experience 

gained while working overseas.

• Environmental and security concerns: FDA has noted that some of 

FDA’s foreign offices are in countries that make recruitment difficult 

due to environmental concerns (such as poor air quality) or security 

concerns (such as dangerous locations). Although hardship pay 

accompanies some of these places, staff may still be hesitant to live in 

these locations for extended periods of time. We reported on this 

challenge in 2010.60

• Personal reasons: Officials said that personal reasons affect the 

willingness of staff to spend time living overseas, such as whether 

spouses will be able to find a job abroad and concerns about the 

educational opportunities available for their children.

• Unfamiliarity with FDA’s global mission: According to FDA officials, 

some FDA staff do not fully understand FDA’s global mission and the 

importance of FDA’s presence overseas. Over the years, FDA has 

been transforming from a domestically focused agency operating in a 

globalized economy to an agency operating in a regulatory 

environment that functions across borders. FDA noted that some 

agencies, such as the Centers for Disease Control and Prevention, 

have a longstanding foreign presence. In contrast, FDA’s foreign 

posts are still relatively new, which presents a number of challenges, 

the agency noted. FDA officials described some of their recruitment 

 58A cost of living adjustment is provided to federal employees posted at overseas 

locations where the cost of goods and services is more expensive, relative to Washington, 

D.C. In addition, FDA staff posted at overseas locations receive benefits that are not 

provided to domestic staff, such as subsidized housing and reimbursed private education 

for staff members’ school age children. In October 2016, FDA officials said that they are 

considering other incentives, including incentive pay, for eligible foreign office employees. 

59See GAO-10-960. 

60See GAO-10-960.
Page 37 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

efforts aimed at educating staff about its increasingly global mission. 

For example, the foreign offices have published blog postings 

highlighting the activities of their offices overseas and how they 

contribute to FDA’s mission. FDA officials also told us they have met 

with selected FDA staff located across the country to advocate foreign 

offices as career considerations.

Another step FDA has taken to help reduce its vacancy rates in its foreign 

offices is to encourage staff to apply for a temporary duty rotation of 30-, 

60-, 90-, or 120-days. In addition to helping the offices fulfill their mission, 

according to FDA, these rotations are a recruitment mechanism that 

allows staff to experience working overseas in the hope that they will 

eventually apply for a full-time position in a foreign office. Since 2011, 37 

FDA staff have completed at least one drug-related temporary rotation in 

an FDA foreign office—some of these people completed more than one 

rotation. Of these 37 staff, 9 (24 percent) went on to work in a full-time 

position overseas.

In addition, to address these challenges, OIP finalized its strategic 

workforce plan in March 2016.61 The plan offers a strategic and long-term 

view of the challenges OIP faces, and addresses the agency’s plan to 

recruit, hire, retain, and develop employees with the skills and abilities to 

fulfill the agency’s global mission, consistent with a recommendation we 

made in 2010.62 We previously recommended that FDA develop a 

strategic workforce plan to help ensure that the agency was able to recruit 

and retain staff with the experience and skills necessary for the foreign 

offices, and to reintegrate returning foreign office staff into FDA’s 

domestic offices. The plan outlines OIP’s activities, performance 

measures, and timeline for addressing its workforce planning challenges. 

The activities are categorized by specific focus areas and include, for 

example, developing a hiring strategy, ensuring that employees 

separating from the agency participate in exit surveys to determine 

actions for improving retention, establishing a succession plan for 

anticipated vacancies, and working to maximize a returning foreign office 

employee’s new skill set from his or her deployment.63 FDA’s workforce 

plan also addresses reintegration challenges and determining how the 

 61OIP has since updated its workforce plan in August 2016.

62See GAO-10-960. 

63The specific focus areas are (1) recruitment and hiring, (2) retention, (3) acclimation, (4) 

training and development, (5) deployment, (6) succession, and (7) reintegration. 
Page 38 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

agency can better leverage the skills staff develop while working abroad, 

which reflects concerns expressed to us by former foreign office staff. For 

example, one activity in the workforce plan is to evaluate FDA’s new 

reintegration policy, which the agency issued in 2015, to determine 

whether it can be made more strategic and career enhancing for 

overseas deployment. Given that this plan has been recently developed, 

FDA has yet to evaluate it, but plans to do so in fiscal year 2017, and, if 

necessary, revise the activities or performance measures specified in the 

plan.

We reviewed OIP’s workforce plan and identified concerns with some of 

the six performance measures OIP developed for the focus areas it plans 

to assess first.64 For example, the recruitment and hiring performance 

measure calls for OIP to reduce its vacancy rate by 5 percent—taking it 

from 32 percent (its vacancy rate at the conclusion of fiscal year 2015) to 

27 percent at the beginning of fiscal year 2017. However, this goal is not 

targeted to the vacancy rates in the foreign offices. Instead, the measure 

targets the OIP-wide vacancy rate. As of July 2016, OIP’s domestic 

offices had a vacancy rate of 34 percent, in contrast to the foreign offices’

collective vacancy rate of 46 percent. Because the 5 percent reduction to 

OIP’s vacancy rate is a combined goal for both domestic and foreign 

offices, OIP could theoretically hire 8 new staff members in its domestic 

offices and achieve its goal without reducing any vacancies in the foreign 

offices.65

 64The workforce plan includes six performance measures for select focus areas. Officials 

told us the performance measures may change upon assessment. Currently, the six 

performance measures (and their accompanying focus area) are (1) reduce the OIP 

vacancy rate by 5 percent from the baseline of 32 percent by the end of fiscal year 2016 

(recruitment and hiring); (2) revise and implement a new employee orientation program by 

the second quarter of fiscal year 2017 (acclimation); (3) refine and document an 

acclimation program specifically for foreign assignments by the second quarter of fiscal 

year 2017 (acclimation); (4) evaluate and measure deployment processing time, monitor 

quarterly, and identify trends and areas for improvement that is within OIP’s control, by the 

first quarter of fiscal year 2017 (deployment); (5) develop a system for tracking 

deployments by the third quarter of fiscal year 2017 (deployment); and (6) develop a 

concept paper on how FDA can better utilize the skills of employees returning from an 

overseas appointment by the first quarter of fiscal year 2017 (reintegration).

65The workforce plan calls for a 5 percent reduction from the baseline vacancy rate of 32 

percent (at the end of fiscal year 2015) to a vacancy rate of 27 percent. However, we 

based our calculations off of the most recent vacancy data available (as of July 2016), 

from which we found that OIP’s vacancy rate had increased to 38 percent. Keeping 

consistent with the goal of a 5 percent reduction to the vacancy rate, our calculations were 

based off of a new goal of a 33 percent vacancy rate. 
Page 39 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Meanwhile, the development of a concept paper on how FDA can better 

leverage the skills of employees returning from overseas, intended as the 

reintegration performance measure, is a positive step, but it does not 

constitute a performance measure. It may serve as a guide, but it does 

not measure FDA’s outcomes in this area. Some of the other 

performance measures identified by FDA also do not measure outcomes. 

For example, the implementation of a new employee orientation program 

may help new foreign office staff better acclimate to their new positions, 

but such a program does not measure outcomes in this area.

A final concern with the workforce plan is that it does not take into 

account the recommendations of the 2016 internal evaluation of the 

foreign offices or the summaries of the operating states and workforce 

compositions of the China, Europe, India, and Latin American offices that 

were completed in 2014. For example, the workforce plan does not reflect 

the recommended foreign office staffing and position types specified in 

the 2016 evaluation, or address how these specifications might be 

achieved.

We have previously reported on the importance of workforce planning, 

which is utilized by agencies to align their workforce with current and 

emerging mission and program goals, and develop long-term strategies 

for acquiring, developing, and retaining staff. Workforce planning helps 

agencies think strategically about how to put the right people with the 

right skills in the right places at the right time. We have previously 

identified key approaches for effective strategic workforce planning. 

These approaches may vary with each agency’s particular needs and 

mission, but should share certain principles, such as identifying skills and 

competencies to fill critical workforce gaps and the strategies needed to 

recruit them; developing specific strategies that are tailored to address 

gaps in number, deployment, and alignment of human capital; and 

monitoring and evaluating the agency’s progress toward its human capital 

goals.66 Similarly, federal internal control standards require agencies to 

establish and operate monitoring activities, evaluate results, and 

remediate deficiencies on a timely basis—which could be done when staff 

are returning from overseas deployments.67 Without a specific focus on 

reducing the number and types of foreign office vacancies, OIP may find 

it difficult for the foreign offices to fulfill their mission. Furthermore, by not 

 66See GAO-04-39.

67See GAO-14-704G. 
Page 40 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

focusing specifically on the foreign offices’ vacancies by position type 

FDA may be missing an opportunity to determine why particular positions 

are more difficult to fill than others and take appropriate action in 

response.

The United States’ increasing dependence on global markets has been 

challenging for FDA. The rapid pace of globalization has complicated the 

agency’s efforts to ensure the safety of our drug supply. Our concerns 

with FDA’s response to globalization go back two decades. In that time 

we have made multiple recommendations to help the agency tackle this 

challenge. The enactment of FDASIA also provided the agency with new 

flexibility to help FDA cope with the growth of drug manufacturing 

overseas. To its credit, FDA has made important strides. It has 

implemented some of our 2008 and 2010 recommendations and is taking 

steps to address others. FDASIA has further enhanced the agency’s 

efforts. To date, FDA has increased the number of foreign drug 

inspections, improved information on foreign establishments 

manufacturing drugs for the U.S. market, and opened offices overseas.

While FDA has made progress on some fronts, it has been incremental 

on others. FDA is now using a single risk-based model to select domestic 

and foreign establishments to inspect so that those that pose the greatest 

risk are prioritized for inspection, but the agency still lacks inspection 

history on approximately 33 percent of foreign establishments. While FDA 

has a plan to fill this knowledge gap over the next few years, this is an 

issue it has been aware of since at least 1988. Given the longevity of this 

issue, it will be important for the agency to fully execute its plan to inspect 

those remaining establishments for which it has no inspection history over 

the next three years.

FDA has also made progress in its strategic planning for the foreign 

offices, but despite these efforts, the agency has yet to determine 

whether the foreign offices meaningfully contribute to drug safety, 

because FDA has no formal process for assessing the offices’ 

contributions. In 2008, the agency determined that opening foreign offices 

was an instrumental part of its response to globalization. Our 

recommendation that FDA develop performance goals and measures for 

these offices followed in 2010, two years after the first office was opened. 

We believe this recommendation has not been fully implemented. The 

two performance measures currently used to assess the foreign offices 

do not fully capture the specific contributions these offices have made. 

While FDA officials shared examples of the foreign offices’

accomplishments, they do not systematically track such information, nor 

Conclusions
Page 41 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

have they fully assessed the extent to which the offices are helping to 

ensure drug safety. We believe it is important for FDA to track these types 

of results-oriented outcomes, and for the agency to determine how their 

performance measures—whether the existing ones or those currently 

being tested—can be used to demonstrate such results. Having 

performance measures that demonstrate results-oriented outcomes will 

better enable FDA to meaningfully assess the foreign offices’

contributions to ensuring drug safety.

FDA should also consider including an examination of the appropriate 

staffing levels for its current foreign offices in its assessment of them.

FDA’s internal evaluation proposed a process for determining the correct 

mix of staffing and position types for the foreign offices, but as OIP has 

yet to implement and apply the process to the foreign offices, such an 

examination has not yet been completed. While the agency’s progress 

overseas may be aggravated by the difficulties it faces in decreasing their 

vacancy rates, the agency must determine what outcomes it is working to 

achieve through these offices and then consider the appropriate staffing 

to reach those goals. Regardless, the current overall foreign office 

vacancy rate of 46 percent could easily undermine even the best strategic 

plan and precludes the offices from being as effective as possible. As we 

also recommended in 2010, FDA has now completed a strategic 

workforce plan for the foreign offices to help ensure that the agency is 

able to recruit and retain staff with the necessary experience. We 

recognize the value of the completion of this plan. However, FDA has not 

fully addressed our recommendation, because some of the reasons for 

the high vacancy rates in the foreign offices are not addressed. While 

FDA may not be able to address some of these reasons, such as time to 

deployment, it is all the more important that it addresses those within its 

span of control, such as addressing the financial concerns raised by staff 

and discussed in our 2010 report, as doing so may contribute to a 

decrease in its foreign office vacancy rate. It is also imperative that FDA 

fully implement its new reintegration program as outlined in the plan. The 

difficulties staff have experienced upon their return to domestic positions 

is one that former foreign office staff repeatedly shared with us when we 

prepared this and our 2010 reports. While the workforce plan contains 

goals and measures, the plan circumvents the high foreign office vacancy 

rate, rather than directly tackling it, by targeting a 5 percent reduction in 

OIP vacancies overall, rather than applying this goal exclusively to the 

foreign offices. The plan also does not target vacancies by specific 

position types. In essence, the current goal targeting OIP vacancies 

overall obscures the underlying challenges the agency faces of staffing 

people overseas and for particular positions. Without targeting the foreign 
Page 42 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

offices specifically or the types of positions most likely to have vacancies, 

FDA will not have a meaningful measure reflecting its true staffing 

position overseas.

FDA’s response has been, in part, that the offices are still new and 

evolving, and it is too soon to expect more than it has already 

accomplished. We believe sufficient time has elapsed for the agency to 

address its remaining challenges. Otherwise, given their significance, 

FDA may not know the extent to which its foreign offices are actually 

assisting the agency it in its efforts to ensure drug safety.

To help ensure that FDA’s foreign offices are able to fully meet their 

mission of helping to ensure the safety of imported products, we 

recommend that the Commissioner of FDA take the following two actions 

as the agency continues to test performance measures and evaluate its 

OIP strategic workforce plan:

1. Assess the effectiveness of the foreign offices’ contributions by 

systematically tracking information to measure whether the offices’

activities specifically contribute to drug safety-related outcomes, such 

as inspections, import alerts, and warning letters.

2. Establish goals to achieve the appropriate staffing level for its foreign 

offices, which would include separating foreign office vacancies from 

the OIP-wide vacancy rate, and setting goals by position type.

We provided a draft of this report to HHS for comment. In its written 

comments, reproduced in appendix V, HHS concurred with our two 

recommendations and said it is taking immediate steps to address them. 

For example, starting in fiscal year 2017, FDA plans to conduct internal 

reviews of its foreign offices’ performances annually, review the offices’ 

programs and efforts at the activity level, and review performance 

indicators. To accomplish this, HHS said that OIP has recently hired two 

designated full-time employees to work on strategic planning, operational 

plans, and performance measures. HHS also said that OIP plans to, 

among other things, adjust its performance measures to track the foreign 

offices’ measures separately from its domestic offices, and characterize 

the offices’ contributions by type of commodity, including drugs. 

Additionally, HHS said that OIP’s strategic workforce plan will be updated 

to reflect the disaggregation of performance measures that track foreign 

office vacancy rates and targets by position type. Furthermore, FDA said 

it is developing recruitment, hiring, retention, and reintegration strategies 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
Page 43 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

to enable the agency to utilize the unique experiences that foreign office 

employees develop overseas. HHS also provided technical comments, 

which we incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Secretary of Health 

and Human Services and the appropriate congressional committees. In 

addition, the report will be available at no charge on the GAO website at 

http://www.gao.gov.

If you or your staff have any questions about this report, please contact 

me at (202) 512-7114 or crossem@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on 

the last page of this report. GAO staff who made key contributions to this 

report are listed in appendix VI.

Marcia Crosse

Director, Health Care
Appendix I: Types of Foreign Drug 

Establishment Inspections Conducted, 

Fiscal Year 2010 through June 30, 2016

Page 44 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Table 4: Food and Drug Administration’s (FDA) Foreign Drug Establishment Inspections by Type of Inspection, Fiscal Year 

(FY) 2010 through June 30, 2016

Type of Inspection FY 2010 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 through June 30, 2016 Total

Surveillance 132 271 351 339 476 527 335 2,431 (55%)

Preapproval/surveillance 260 257 253 258 267 250 101 1,646 (38%)

Preapproval 44 24 17 25 13 23 43 189 (4%)

For-causea 4 7 4 14 23 42 24 118 (3%)

Total 440 559 625 636 779 842 503 4,384

Source: GAO analysis of FDA data. | GAO-17-143

a

This row includes any inspection that included a “for-cause” component. For-cause inspections are 

conducted to investigate consumer complaints, reports of product quality defects submitted by 

consumers or health care professionals, or indications of potential manufacturing problems submitted 

by the manufacturers themselves, among other reasons.

Appendix I: Types of Foreign Drug 

Establishment Inspections Conducted, 

Fiscal Year 2010 through June 30, 2016
Appendix II: Drug Establishments that the 

Food and Drug Administration May Never Have 

Inspected

Page 45 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Table 5: Drug Establishments in the Food and Drug Administration’s (FDA) Fiscal Year 2017 Catalog That May Never Have 

Been Inspected, by Country

Establishments Establishments that may 

never have been inspecteda Percent of establishments that may never have been 

inspected

India 572 189 33%

China 535 243 45%

Germany 191 25 13%

South Korea 171 154 90%

Canada 166 45 27%

Japan 162 36 22%

France 146 35 24%

Italy 146 23 16%

United Kingdom 136 37 27%

Switzerland 89 10 11%

All other countries 709 194 27%

Foreign total 3,023 991 33%

Domestic total 2,026 291 14%

Source: GAO analysis of FDA data. | GAO-17-143

a

This count represents the number of establishments for which FDA could not identify a previous 

surveillance inspection when FDA compiled its catalog of establishments subject to inspection for 

fiscal year 2017.

Appendix II: Drug Establishments that the 

Food and Drug Administration May Never 

Have Inspected
Appendix III: Number of Foreign Drug 

Inspections in which Temporary Duty Staff 

Participated

Page 46 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Table 6: Number of Drug Inspections in which Temporary Duty Staff Assigned to the Food and Drug Administration’s (FDA) 

Foreign Offices Participated, Fiscal Year (FY) 2012 through June 30, 2016

FDA Foreign Office FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 

through June 

30, 2016

Total

China office 8 7 30 12 22 79

India office 0 1 9 8 8 26

Total 8 8 39 20 30 105

Source: GAO analysis of FDA data. | GAO-17-143

Note: Temporary duty staff did not conduct any foreign inspections in fiscal year 2010 or fiscal year 

2011. Additionally, the number zero indicates that no drug inspections were conducted by temporary 

duty staff assigned to the foreign offices in that country in that fiscal year.

Appendix III: Number of Foreign Drug 

Inspections in which Temporary Duty Staff 

Participated
Appendix IV: Efforts by the Food and Drug 

Administration’s Foreign Offices to Enhance 

Drug Safety

Page 47 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

The Food and Drug Administration’s (FDA) foreign offices have helped 

ensure drug safety by collaborating with foreign counterparts in their host 

countries. According to FDA officials, each foreign office had examples of 

collaborative activities with their respective foreign counterparts that may 

have increased drug safety. For example, FDA’s China and India offices 

both conducted workshops on the importance of data integrity for industry 

representatives and foreign regulators, while the Latin America office

sponsored a training session for Mexican regulators on current good 

manufacturing practices and inspections. See table 7 for examples of 

activities from each foreign office provided by FDA officials that may have 

helped ensure the safety of drugs entering the United States.

Table 7: Food and Drug Administration (FDA) Examples of Foreign Office Activities that May Have Resulted in Increased Drug 

Safety

FDA foreign office Examples of activities related to enhancing drug safety

China office • In May 2012, the China Food and Drug Administration requested help from FDA’s China office to 

verify a list of Chinese language websites selling adulterated dietary supplements and medical 

products to Chinese and U.S customers. FDA’s China office verified the list of websites supplied by 

the China Food and Drug Administration and forwarded the information to FDA headquarters. The 

following month, FDA headquarters sent requests to the companies responsible for managing the 

websites to take action, which then reported back to FDA headquarters that the websites had been 

disabled.

• In January 2015, FDA headquarters provided its China office with information about a biotechnology 

firm that was manufacturing and distributing counterfeit drugs to various countries, including the 

United States. FDA’s China office investigated the firm’s website and collected additional evidence 

demonstrating that the firm was selling counterfeit drugs. In March 2015, FDA’s China office notified 

the China Food and Drug Administration about the case and provided the foreign regulator with 

supporting documents and evidence. The case was then brought to the Chinese Public Security 

Bureau, which seized the counterfeit drugs and money and shut down the site.

• FDA’s China office led the in-country effort to gather intelligence on establishments that manufactured 

FDA-regulated products that could potentially be impacted by explosions at two separate chemical 

warehouses in Tianjin, China in August and October 2015. Screening criteria were put in place for all 

FDA-regulated products being imported from the Tianjin area. During the period of increased 

screening, two drug product entries were detected with elevated levels of cyanide. FDA detained and 

refused the products and alerted the China Food and Drug Administration that the products would be 

returned to China. Subsequently, the China Food and Drug Administration inspected the 

manufacturer’s establishment, confirmed cyanide contamination had occurred, and halted production 

of the products until the contamination was addressed.

• FDA’s China office has held workshops to educate regulators from China’s Food and Drug 

Administration and industry about the importance of data integrity. For example, a workshop held in 

August 2015 had over 1,200 participants. At the conclusion of the training, the China office provided a 

survey for participants to complete. From the 202 responses the China office received, 54 participants 

indicated they planned to upgrade their data management software; 21 said they planned to revise 

their standard operating procedures; and 67 indicated they planned to conduct training on the 

importance of data integrity to their workforces. To continue to address the need of stakeholders, 

additional workshops on current good manufacturing practices and good clinical practices are 

planned to be held throughout China in October 2016 and November 2016, respectively.

Appendix IV: Efforts by the Food and Drug 

Administration’s Foreign Offices to Enhance 

Drug Safety
Appendix IV: Efforts by the Food and Drug 

Administration’s Foreign Offices to Enhance 

Drug Safety

Page 48 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

FDA foreign office Examples of activities related to enhancing drug safety

India office • In 2012, the India office discovered that a drug manufacturer in Western India manufactured and 

distributed drugs from one of its sites without fulfilling FDA’s registration requirements. The FDA India 

office contacted FDA headquarters and was instructed by FDA to initiate an inspection at both the 

manufacturer’s registered and non-registered sites. The inspections uncovered major deficiencies 

with current good manufacturing practices, and FDA issued a warning letter to the manufacturer and 

placed the sites on import alert.

• An Indian company manufactured drugs linked to deaths in Pakistan in 2013. For security reasons, 

the U.S. Embassy in India prohibited an FDA inspection of the facility. Instead, the India office 

obtained information about the company’s facilities from the local Indian government inspection, 

which had found the facility to be in a poor state of compliance with current good manufacturing 

practices. Additionally, the owner was found to be involved in significant criminal activities. Both the 

manufacturer and its affiliate were placed on import alert as a result of the India office’s informationgathering.

• The India office hosted a workshop for Indian regulators in April 2016 on emerging good clinical 

practice issues, regulatory updates, and practical approaches to inspectional methods, tools, report 

writing, fraud detection, and assessment of clinical trial data integrity. The goals of the workshop were 

for participants to be able to (1) identify general concepts utilized by regulatory investigators when 

performing inspections of clinical investigators, clinical trial sites and ethics committees; (2) identify 

techniques for detecting bias and the accuracy of data in clinical trials; and (3) develop evidence and 

determine the appropriate observations to include in the inspection report. Approximately 60 Indian 

regulators attended the workshop.

Europe office • According to the Europe office, a primary focus of the office has been enhancing the exchange of 

information between the FDA and European regulatory counterparts. One way the office 

accomplishes this is through the development of a legal infrastructure that permits more expeditious 

exchanges of information. According to the Europe office, the office has been successful in signing 

confidentiality agreements with European regulatory agencies, resulting in more than two times the 

number of such agreements the agency had in place since the Europe office opened. As of May 

2016, the Europe office reported FDA had 37 confidentiality agreements encompassing 17 European 

countries and 6 confidentiality agreements in place with the European Union.

• According to FDA, Swiss law bars foreign investigators from doing inspections of drug establishments 

inside Switzerland. However, FDA investigators can obtain a waiver in order to gain access to Swiss 

establishments. FDA’s Europe office was responsible for working with Swiss regulators to request 

and approve such waivers for FDA’s investigators until 2012. After this time, FDA’s Office of 

Regulatory Affairs became responsible for requesting the waivers, but the Europe office is still the 

primary point of contact with Swiss regulators if they need more information to approve such waivers.

Latin America office • In September 2011, FDA conducted an inspection of a Mexican establishment producing drugs and 

issued a warning letter based on the outcomes of the inspection in April 2012. Prior to issuing the 

warning letter, the Latin America office communicated with Mexican regulators about the deficiencies 

found in the inspection. As a result of this information, Mexican regulators suspended the production 

of several drug products by the manufacturer and issued a recall of one of its products.

• In September 2013, the Mexico post of the Latin America office developed and delivered a one-week 

training session for investigators and compliance officers from Mexico’s drug regulatory agency with 

the purpose of providing instruction on FDA’s current good manufacturing practice standards for 

manufacturers and FDA’s inspection techniques. The training included, among other topics, current 

good manufacturing practices for drugs, establishment inspections, inspection classifications, 

regulatory actions, and data integrity. Twenty regulatory counterparts (investigators and compliance 

officers) from Mexico’s regulatory agency participated in this training session.

Source: GAO review of FDA provided foreign office information. | GAO-17-143
Appendix V: Comments from the Department 

of Health and Human Services

Page 49 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Appendix V: Comments from the Department 

of Health and Human Services
Appendix V: Comments from the Department 

of Health and Human Services

Page 50 GAO-17-143 FDA’s Foreign Offices and Drug Inspections
Appendix V: Comments from the Department 

of Health and Human Services

Page 51 GAO-17-143 FDA’s Foreign Offices and Drug Inspections
Appendix V: Comments from the Department 

of Health and Human Services

Page 52 GAO-17-143 FDA’s Foreign Offices and Drug Inspections
Appendix V: Comments from the Department 

of Health and Human Services

Page 53 GAO-17-143 FDA’s Foreign Offices and Drug Inspections
Appendix V: Comments from the Department 

of Health and Human Services

Page 54 GAO-17-143 FDA’s Foreign Offices and Drug Inspections
Appendix VI: GAO Contact and Staff 

Acknowledgments

Page 55 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact named above, Geri Redican-Bigott (Assistant 

Director), Kaitlin Coffey (Analyst in Charge), Nick Bartine, George Bogart, 

Zhi Boon, Muriel Brown, Drew Long, and Michael Rose made key 

contributions to this report.

Appendix VI: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments
Related GAO Products

Page 56 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

High-Risk Series

High-Risk Series: An Update. GAO-15-290. Washington, D.C.: February 

2015.

High-Risk Series: An Update. GAO-13-283. Washington, D.C.: February 

2013.

High-Risk Series: An Update. GAO-11-278. Washington, D.C.: February 

2011.

High-Risk Series: An Update. GAO-09-271. Washington, D.C.: January 

2009.

Reports and Testimonies

Food Safety: Additional Actions Needed to Help FDA’s Foreign Offices 

Ensure Safety of Imported Food. GAO-15-183. Washington, D.C.: 

January 30, 2015.

Drug Safety: FDA Has Conducted More Foreign Inspections and Begun 

to Improve its Information on Foreign Establishments, but More Progress 

is Needed. GAO-10-961. Washington, D.C.: September 30, 2010.

Food and Drug Administration: Overseas Offices Have Taken Steps to 

Help Ensure Import Safety, but More Long-term Planning Is Needed. 

GAO-10-960. Washington, D.C.: September 30, 2010.

Drug Safety: Better Data Management and More Inspections Are Needed 

to Strengthen FDA’s Foreign Drug Inspection Program. GAO-08-970. 

Washington, D.C.: September 22, 2008.

Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have 

Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug 

Inspection Program. GAO-08-701T. Washington, D.C.: April 22, 2008.

Drug Safety: Preliminary Findings Suggest Weaknesses in FDA’s 

Program for Inspecting Foreign Drug Manufacturers. GAO-08-224T. 

Washington, D.C.: November 1, 2007.

Human Capital: Key Principles for Effective Strategic Workforce Planning, 

GAO-04-39. Washington, D.C.: December 11, 2003.

Related GAO Products
Related GAO Products

Page 57 GAO-17-143 FDA’s Foreign Offices and Drug Inspections

Food and Drug Administration: Improvements Needed in the Foreign 

Drug Inspection Program. GAO/HEHS-98-21. Washington, D.C.: March 

17, 1998.

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