Contains Nonbinding Recommendations  
 
 
 
Refusal of Inspection by a Foreign 
Food Establishment or Foreign 
Government: 
Guidance for Industry 
 
 
 
You may submit electronic or written comments regarding this guidance at any time. Submit 
electronic comments to https://www.regulations.gov. Submit written comments to Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. All comments should be identified with the docket number 
FDA-2017-D-6528 listed in the notice of availability published in the Federal Register.  
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 
October 2022 
 
    Contains Nonbinding Recommendations  
   
 
 
Table of Contents 
 
I.  Introduction 
II. Background 
A. Statutory Authority 
B.  Scheduling Foreign Food Establishment Inspections 
C. Establishment Inspection Activities 
III.  Refusal of Inspection 
A. Refusal of Inspection by a Foreign Food Establishment 
i.  Refusal by a Foreign Food Establishment to Permit 
Scheduling of an Inspection 
ii.  Refusal by a Foreign Food Establishment to Permit 
Conducting an Inspection 
B.  Refusal of Inspection by a Foreign Government 
i.  Refusal by a Foreign Government to Permit Scheduling of 
an Inspection 
ii.  Refusal by a Foreign Government to Permit Conducting an 
Inspection 
IV. FDA Enforcement of Section 807(b) of the Federal Food, Drug, 
and Cosmetic Act 
A. Refusal by a Foreign Food Establishment 
B.  Refusal by a Foreign Government 
V. References 
 
   
  2  Contains Nonbinding Recommendations  
   
 
Refusal of Inspection by a Foreign 
Food Establishment or Foreign 
Government: 
1 
Guidance for Industry
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
 
I. Introduction 
 
This guidance provides information for foreign food establishments subject to our 
inspection, as well as for foreign governments, on how we interpret refuses to permit 
entry ... to inspect a foreign food establishment, pursuant to section 807(b) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384c(b)). The examples 
used in this guidance are not intended to serve as an exhaustive list. Rather, they 
illustrate situations that we may encounter in preparing for and conducting inspections. 
 
Terms used in this guidance include: 
  The term U.S. refers to the United States. 
  The pronouns we, our, and us refer to FDA. 
  The term food means: (1) articles used for food or drink for man or other 
animals, (2) chewing gum, and (3) articles used for components of any such 
article.  (Section 201(f) of the FD&C Act (21 U.S.C. 321(f)). 
  The term foreign food establishment or establishment is used in this guidance 
to refer to a foreign factory, warehouse, or other establishment that grows, 
harvests, manufactures, processes, packs, or holds, food.  Establishments as 
used in this guidance include farms (as defined in 21 CFR 1.227 and 112.3). 
  The term owner, operator, or agent in charge is used in this guidance to refer to 
the owner, operator, or agent in charge of the foreign food establishment, or an 
individual authorized by the owner, operator, or agent in charge of the foreign 
 
 
 
1 This guidance was prepared by the Office of Compliance in the Center for Food Safety and Applied 
Nutrition in cooperation with the Center for Veterinary Medicine and the Office of Regulatory Affairs. 
  3  Contains Nonbinding Recommendations  
   
 
 
 
food establishment, to be the contact person for the purposes of our inspection. 
  The term FDA investigators refers to United States inspectors or other 
individuals duly designated by the Secretary. (Sec. 807(b) of the FD&C Act (21 
U.S.C. 384c(b)) 
  The term foreign governments refers to foreign governments and competent 
authorities of foreign countries. 
 
Our guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements 
are cited.  The use of the word should in FDA guidances means that something is 
suggested or recommended, but not required. 
 
This guidance document provides examples of situations that we may consider to be 
refuses to permit entry ... to inspect by a foreign food establishment or foreign 
government, pursuant to section 807(b) of the FD&C Act.  FDA staff (e.g., inspection 
scheduling personnel, investigators) who identify potential refusal of inspection 
situations will refer the information to agency management to determine whether to 
refuse admission of food into the United States. 
 
II.  Background 
 
FDA food establishment inspections are, among other things, designed to identify 
potential food safety  concerns, both for domestically produced and imported foods. 
 
A. Statutory Authority 
 
Under section 704 of the FD&C Act, duly designated representatives of FDA, upon 
presenting appropriate credentials and a written notice to the owner, operator, or agent in 
charge are authorized to enter and inspect at reasonable times, within reasonable limits, 
and in a reasonable manner any factory, warehouse, or establishment in which food is 
manufactured, processed, packed, or held for introduction into interstate commerce or 
after such introduction.  Section 201(b)(1) of the FD&C Act (21 U.S.C. 321(b)(1)) 
defines interstate commerce, in part, as "commerce between any State or Territory and 
any place outside thereof." Therefore, food from foreign establishments that is imported 
into or offered for sale in the United States is in interstate commerce and FDA may 
inspect such establishments. 
 
The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353), enacted on 
January 4, 2011, amended the FD&C Act to expand and enhance our ability to ensure 
that imported food products meet United States standards and are safe for consumers. 
Section 421 of the FD&C Act (21 U.S.C. 350j), added by section 201 of FSMA, reflects 
Congressional intent for an increase in the number of domestic and foreign inspections. 
 
Section 807(b) of the FD&C Act (21 U.S.C. 384c(b)), added by section 306 of FSMA, 
provides that FDA shall refuse admission of a food into the United States if it is from a 
  4  Contains Nonbinding Recommendations  
   
 
foreign factory, warehouse, or other establishment of which the owner, operator, or agent 
in charge, or the government of the foreign country, refuses to permit entry of United 
States inspectors or other individuals duly designated by the Secretary, upon request, to 
inspect such factory, warehouse, or other establishment.  In the domestic context, FDA 
has authority to compel inspection, namely, when a domestic firm refuses inspection 
completely or refuses to permit us to fully conduct an inspection (e.g., refuses to provide 
access to applicable records, refuses to permit the investigator to take photographs as 
necessary or refuses to permit sample collection), FDA may seek an inspection warrant to 
compel the inspection. (See FDA Regulatory Procedures Manual Section 6-3  Inspection 
Warrants.  See also, Dow Chemical Co. v. United States, 476 U.S. 227, 233 (1986) 
(Regulatory or enforcement authority generally carries with it all the modes of inquiry 
and investigation traditionally employed or useful to execute the authority granted.); 
United States v. Chungs Prods. LP, 941 F. Supp. 2d 770, 777 (S.D. Tex. 2013)). 
 
Section 807(b) of the FD&C Act also provides that an owner, operator, or agent in 
charge shall be considered to have refused an inspection if such owner, operator, or agent 
in charge does not permit an inspection of a factory, warehouse, or other establishment 
during the 24-hour period after [we submit an inspection request], or after such other 
time period, as agreed upon by [FDA] and the foreign factory, warehouse, or other 
establishment. 
 
B. Scheduling Foreign Food Establishment Inspections 
 
The FD&C Act does not require us to pre-announce our inspections. However, for 
inspections of foreign food establishments, our general practice is to contact the firm 
before an FDA investigator arrives at the inspection site. This pre-announcement, 
although not required, is intended to facilitate the inspection process and ensure that 
appropriate records and personnel will be made available. 
 
To schedule inspections of foreign food establishments and to enter the foreign country to 
conduct the inspections, we coordinate with both the establishments to be inspected and 
the foreign government or competent authority of the foreign country in which the 
foreign food establishments to be inspected are located. 
 
FDA recognizes the importance of coordinating with the competent authorities of foreign 
governments regarding inspections.  Before scheduling inspections of foreign food 
establishments, we send a written inspection request to each foreign government 
regarding our  intent to inspect food establishments in its country.  We then notify each 
foreign food  establishment of our intent to schedule and conduct an inspection. We may 
use several forms of communication, including email, fax, mail, or express courier 
service, to send the written inspection request to schedule an inspection to the owner, 
operator, or agent in charge of the establishment, to the establishments U.S. agent (if 
applicable), and to the foreign government.  After we request to schedule an inspection, 
we follow up as necessary using one or more communication mechanisms (e.g., email, 
fax, mail, express courier service, and telephone calls) to establish and coordinate the 
inspection schedule.  The inspection request and the pre-inspection communications are 
intended to facilitate the inspection process and ensure that appropriate personnel and 
records will be available to us during the inspection.  When establishing an inspection 
  5  Contains Nonbinding Recommendations  
   
 
date, we consider the establishments operating schedule and factors that may impact that 
schedule, e.g., seasonality; weather, security situations, and other local conditions; and 
other non-business days. 
 
After scheduling the inspections, we provide the foreign government with written 
confirmation of the scheduled dates of the inspections. Representatives of the foreign 
government may accompany the FDA investigator during an inspection. 
 
C. Establishment Inspection Activities 
 
During an inspection, the FDA investigator typically observes the areas of the food 
establishment where FDA-regulated foods are grown, harvested, manufactured, 
processed, prepared, packed, or held and areas that may impact these operations.  The 
FDA investigator may observe food-related operations (e.g., food production and 
processing operations, receiving of raw materials, warehousing, and sanitization of 
equipment).  
 
During an inspection, the FDA investigator may review hardcopy and electronic records 
relating to the food and food-related operations, as authorized by applicable laws and 
regulations. We recognize that an owner, operator, or agent in charge may need some 
time to procure requested records.  Thus, the FDA investigator will attempt to 
accommodate reasonable delays in response to a request for records or copies of records, 
provided the delays appear to be in the context of a good faith effort to comply with the 
request.  
 
The FDA investigator may take photographs as necessary to present an objective and 
contemporaneous representation of establishment conditions.  Examples of conditions or 
practices effectively documented by photographs include evidence of rodents or insect 
infestation; faulty construction or maintenance of equipment or facilities; product storage 
conditions; product labels and labeling; manufacturing and various control records; 
employee practices contributing to contamination or to violative conditions; and visible 
contamination of raw materials or finished products.  
 
The FDA investigator also may collect samples during an inspection (e.g., environmental 
samples, finished product samples, raw material samples, and in-line or in-process 
material samples).  
 
III.  Refusal of Inspection 
 
We consider the language in section 807(b) of the FD&C Act that states, refuses to 
permit entry [of an FDA investigator] to inspect and does not permit an inspection to 
include statements, actions, and passive behaviors that prevent or delay us from 
scheduling or fully conducting an inspection.  Refusal also includes statements, actions, 
and passive behaviors intended to avoid inspection or to mislead or deceive the FDA 
investigator in a manner that prevents the investigator from conducting the inspection. 
 
Under section 807(b) of the FD&C Act, FDA shall refuse admission into the United 
  6  Contains Nonbinding Recommendations  
   
 
States of a food from a foreign food establishment of which the owner, operator, or agent 
in charge or the foreign government refuses to permit an inspection.   
 
A. Refusal of Inspection by a Foreign Food Establishment 
 
i.  Refusal by a Foreign Food Establishment to Permit Scheduling of 
an Inspection 
 
We consider an owner, operator, or agent in charge of a foreign food establishment to have 
refused an inspection when that owner, operator, or agent in charge prevents or delays the 
FDA from scheduling the inspection.  For example, we consider an owner, operator, or 
agent in charge of a foreign food establishment to have refused an inspection if the owner, 
operator, or agent in charge does not respond to us during the 24-hour period after we 
submit a written inspection request.  We may submit the request by email, fax, mail, or 
express courier service.  We will ordinarily consider that we have submitted an inspection 
request to an owner, operator, or agent in charge when the establishment receives the 
request to schedule an inspection or should have received the request based on 
documentation of delivery.  We will use documentation of the time that the owner, 
operator, or agent in charge initiated or sent the response (e.g., date and time of telephone 
call, email, fax, mail, or express courier service) to determine whether the owner, operator, 
or agent in charge responded during the 24-hour period, or other agreed upon time period, 
after we submitted the inspection request.  We will ordinarily consider circumstances that 
may delay delivery of an owner, operator, or agent in charges response, when known, 
such as if an establishment is located in an area that has limited access to mail, express 
courier services, or the Internet, or the date of receipt is a non-business day. 
 
We also generally consider that an owner, operator, or agent in charge has refused an 
inspection if the owner, operator, or agent in charge: 
  stops communicating with us at any time after the owner, operator, or agent in 
charge initially responds to our request to schedule an inspection, 
  provides an incomplete or inaccurate response relevant to an FDA inspection 
(e.g., an owner, operator, or agent  in charge claims the establishment is not 
operating or does not ship food to the United States, when FDA has reliable 
information to the contrary in its databases or from other sources), 
  rejects FDAs attempt to schedule an inspection either directly or by not 
agreeing to an inspection start date and does not give a reasonable explanation 
for its failure to do so, or 
  agrees to an inspection start date and then requests a later date without giving a 
reasonable explanation. 
 
We do not consider a request to delay or reschedule an inspection to constitute a refusal 
of inspection when the delay or rescheduling is based on an unforeseen event or situation, 
such as a severe weather event that prevents the establishment from operating on the 
dates we proposed or scheduled.  We may request documentation of the event or 
situation.  The request by an owner, operator, or agent in charge to delay or reschedule an 
inspection should include the earliest possible date an inspection can be scheduled. For 
example, if the inspection must be rescheduled because the establishment is temporarily 
closed, we expect the owner, operator, or agent in charge to provide the date the 
  7  Contains Nonbinding Recommendations  
   
 
establishment will reopen. 
 
FDAs written request to the owner, operator, or agent in charge of the establishment to 
schedule an inspection will explain the consequences of a refusal of inspection (i.e., 
section 807(b) of the FD&C Act provides that FDA shall refuse admission of food from 
the establishment into the United States).  
 
ii.  Refusal by a Foreign Food Establishment to Permit Conducting an 
Inspection 
 
We consider an owner, operator, or agent in charge of a foreign food establishment to have 
refused an inspection when that owner, operator, or agent in charge prevents the FDA 
investigator from entering the establishment.  Examples of where we would generally 
consider an owner, operator, or agent in charge to be preventing the FDA investigator from 
entering the establishment include: 
  The owner, operator, or agent in charge refuses to permit entry to the 
establishment. 
  The owner, operator, or agent in charge sends staff home for the day, without a 
reasonable explanation, and tells the FDA investigator that the establishment is 
not producing any product. 
  The establishment is not operating when the FDA investigator arrives at the 
establishment at the scheduled time, and the owner, operator, or agent in charge 
does not provide a reasonable explanation. 
  The owner, operator, or agent in charge does not answer telephone calls from the 
FDA investigator who is present at the establishment and unable to gain entry to 
the establishment for purposes of conducting an inspection, and there is evidence 
that the establishment is operating. 
 
We consider an owner, operator, or agent in charge of a foreign food establishment to have 
refused an inspection when an owner, operator, or agent in charge prevents the FDA 
investigator from fully conducting an inspection of the establishment, by establishing 
unreasonable preconditions to allowing the inspection or by preventing or interfering with 
completion of some aspect of the inspection.  Examples of where we would generally 
consider preventing the FDA investigator from fully conducting an inspection include: 
  The owner, operator, or agent in charge bars the FDA investigator from an area of 
the establishment where food is grown, harvested, manufactured, processed, 
prepared, packed, or held or an area of the establishment that may impact these 
operations (e.g., the owner, operator, or agent in charge does not unlock an area of 
the establishment or does not take other action necessary to permit access by the 
FDA investigator). 
  The owner, operator, or agent in charge does not allow the FDA investigator to 
inspect an area of the establishment because certain staff members are not 
present, without a reasonable explanation. 
  The owner, operator, or agent in charge states that direct observation of an 
establishment, in whole or in part, must be limited to an unreasonably short 
amount of time, thus preventing FDA from inspecting the establishment as is 
usual and customary. 
  8  Contains Nonbinding Recommendations  
   
 
  The owner, operator, or agent in charge orders the discontinuation of all 
manufacturing for the duration of the FDA inspection without a reasonable 
explanation. 
  The owner, operator, or agent in charge causes the FDA investigator to leave the 
premises before the inspection is completed. 
  The owner, operator, or agent in charge refuses to allow the FDA investigator to 
collect evidence to document potential violations (e.g., to take photographs as 
necessary; to collect samples; talk to pertinent staff; or to collect food labels and 
labeling). 
  The owner, operator, or agent in charge refuses or limits the FDA investigators 
access to records that are within FDAs authority to review and copy.  Examples 
of such record refusals include: 
  The owner, operator, or agent in charge refuses to allow the FDA 
o
investigator to review the requested records; provides some, but not all, of 
the  requested records or fails to produce the records within a reasonable 
timeframe, as discussed with the owner, operator, or agent in charge. 
  The owner, operator, or agent in charge provides the requested records to 
o
the FDA investigator, but the records are edited to remove information 
that is relevant to our inspection. 
  The owner, operator, or agent in charge does not allow the FDA 
o
investigator to make copies of records as allowed by statute or regulation. 
  The owner, operator, or agent in charge prevents or limits the FDA investigators 
collection of samples for analysis. 
 
We generally consider an owner, operator, or agent in charge of a foreign food establishment 
to have refused an inspection when that owner, operator, or agent in charge causes a delay 
after the inspection has begun that interferes with the FDA investigator conducting an 
inspection as is usual and customary.  Examples of where we would generally consider an 
owner, operator, or agent in charge to be refusing an inspection by causing a delay during 
the inspection include: 
  The owner, operator, or agent in charge does not allow the FDA investigator 
access to an area of the establishment until a specific future date or time even 
though food is being grown, harvested, manufactured, processed, prepared, 
packed, or held in that area of the establishment or does not allow access to an 
area of the establishment that may impact these operations (e.g., a room where 
equipment is sanitized; an area where cleaning materials or other chemicals are 
stored). 
  The owner, operator, or agent in charge leaves the FDA investigator in a non-
production area of the establishment (e.g., conference room) without access to 
records, to a responsible individual, or to other areas of the establishment that 
would be subject to inspection for an unreasonable period of time that interferes 
with the investigators ability to complete the inspection. 
 
B. Refusal of Inspection by a Foreign Government 
 
i.  Refusal by a Foreign Government to Permit Scheduling of an 
Inspection 
  9  Contains Nonbinding Recommendations  
   
 
 
We consider a foreign government to have refused an inspection if, upon our request to 
conduct an inspection, the foreign government prevents or delays us from scheduling an 
inspection. Examples of what we would generally consider to be such a refusal include: 
  The foreign government does not allow us to schedule an inspection and does not 
provide or suggest a reasonable alternative date or time frame for scheduling the 
inspection. 
  The foreign government causes a delay that prevents us from scheduling an 
inspection in a timely manner and does not provide a reasonable explanation for 
the delay. 
  The foreign government does not allow an FDA investigator to enter the country 
(e.g., the foreign government denies a visa for an FDA investigator and does not 
provide a reasonable explanation for the denial). 
 
ii.  Refusal by a Foreign Government to Permit Conducting an 
Inspection 
 
We consider a foreign government to have refused an inspection when the foreign 
government prevents the FDA investigator from entering the establishment.  Examples 
of what we would generally consider to be such a refusal include: 
  The foreign government does not allow the FDA investigator to inspect a 
specific type of food establishment. 
  The foreign government requests the FDA investigator to leave the country 
before a scheduled inspection is conducted. 
 
We also consider a foreign government to have refused an inspection when the foreign 
government prevents the FDA investigator from fully conducting an inspection of the 
establishment by establishing unreasonable preconditions to allowing the inspection or 
by preventing or interfering with completion of some aspect of the inspection.  Examples 
of what we would generally consider to be preventing the FDA investigator from fully 
conducting an inspection include: 
  The foreign government bars the FDA investigator from an area of the 
establishment where food is grown, harvested, manufactured, processed, 
prepared, packed, or held. 
  The foreign government refuses to allow the FDA investigator to take 
photographs as necessary.  
  The foreign government refuses or limits access to records requested by  the 
FDA investigator that are within FDAs authority to review and copy.  Examples 
include: 
  The foreign government refuses to allow the FDA investigator to review 
o
the requested records, provides some, but not all, of the requested 
records, or fails to produce the requested records within the requested 
timeframe. 
  The foreign government provides the requested records to the FDA 
o
investigator, but the records are edited to remove information relevant to 
our inspection. 
  The foreign government prevents or limits the FDA investigators collection of 
  10  Contains Nonbinding Recommendations  
   
 
samples for analysis. 
 
In addition, we generally consider a foreign government to have refused an inspection when 
the foreign government delays the FDA investigator from conducting an inspection of the 
establishment after the inspection has begun and the delay interferes with the FDA 
investigator conducting an inspection as is usual and customary.  Examples of where we 
would generally consider a foreign government to be refusing an inspection by causing 
delays during an inspection include: 
  The foreign government does not allow the FDA investigator access to an area of 
the establishment until a specific future date or time even though food is being 
grown, harvested, manufactured, processed, prepared, packed, or held in that area 
of the establishment or does not allow access to an area of the establishment that 
may impact these operations (e.g., a room where equipment is sanitized; an area 
where cleaning materials or other chemicals are stored). 
  The foreign government leaves the FDA investigator in a non-production area of 
the establishment (e.g., conference room) without access to records, to a 
responsible individual, or to other areas of the establishment that would be 
subject to inspection for an unreasonable period of time that interferes with the 
investigators ability to complete the inspection. 
 
IV.  FDA Enforcement of Section 807(b) of the Federal Food, 
Drug, and Cosmetic Act 
 
Our Import Alert 99-32 Detention Without Physical Examination of Products From Firms  
Refusing FDA Foreign Establishment Inspection includes a Red List that identifies 
foreign food establishments for which the owner, operator, or agent in charge, or foreign 
government has refused an inspection.  Food offered for entry into the United States from 
an establishment identified on the Red List of Import Alert 99-32 is subject to refusal of 
admission as set forth in section 807(b) of the FD&C Act.  When FDA makes a 
preliminary determination that an imported article of food is subject to refusal of 
admission under section 807(b) of the FD&C Act (including food from establishments 
identified on the Red List of Import Alert 99-32), FDA intends to follow the same notice 
and hearing process laid out in section 801(a) of the FD&C Act (21 U.S.C. 381) and 21 
CFR 1.94(a) that applies to imported articles under section 801(a) of the FD&C Act. 
 
A. Refusal by a Foreign Food Establishment 
 
As explained in section III.A. of this guidance, FDAs written request to the owner, 
operator, or agent in charge of the establishment to schedule an inspection will explain 
the consequences of a refusal of inspection (i.e., section 807(b) of the FD&C Act 
provides that FDA shall refuse admission of food from the establishment into the United 
States).  Additionally, if an FDA investigator who is attempting to conduct an inspection 
believes that the owner, operator, or agent in charge of the establishment, or the foreign 
government, is refusing the inspection, the FDA investigator will make reasonable 
efforts to inform the owner, operator, or agent in charge of the establishment of the 
consequences of the refusal. 
 
  11  Contains Nonbinding Recommendations  
   
 
Based on FDAs review of the evidence of a refusal of inspection, FDA may determine 
that the foreign establishment refused the inspection under section 807(b) of the FD&C 
Act.  After FDA makes this determination, we may place the establishment on the Red 
List of Import Alert 99-32.  We will notify the owner, operator, or agent in charge of the 
establishment of FDAs determination of the refusal of inspection and of our decision to 
place the establishment on the Red List of Import Alert 99-32. 
 
The owner, operator, or agent in charge of the establishment may at any time contest, in 
writing, FDAs decision to place them on the Red List of Import Alert 99-32.  For 
example, they may present evidence to FDA to support their claim that the Agency should 
not have considered them to have refused an inspection.  In addition, the owner, operator, 
or agent in charge may ask FDA to remove them from the Red List of Import Alert 99-32 
by submitting a request (which may include copies of inspection reports for inspections 
performed by third parties) to schedule an FDA inspection of the establishment.  To 
contest FDAs decision or to schedule an FDA inspection, the owner, operator, or agent in 
charge of the establishment should send a written request by email to 
Importalerts2@fda.hhs.gov or by mail or express courier service to: 
 
Food and Drug Administration 
Division of Import Operations 
12420 Parklawn Drive 
ELEM 3109 
Rockville, MD 20857 
 
If an establishment has refused an inspection, but later requests FDA to reschedule an 
inspection, we will attempt to reschedule an inspection.  However, when planning any 
foreign food establishment inspection, we still need to weigh and consider factors that 
affect scheduling (e.g., current inspection priorities, availability of inspection personnel, 
U.S. State Department Travel Warnings and Alerts, and other foreign travel 
considerations, including coordination with the foreign government).  Therefore, in some 
situations, it may be at least a year before FDA can return to inspect an establishment 
that refused, but later requests, an inspection. 
 
B. Refusal by a Foreign Government 
 
When the foreign government indicates it will refuse inspection of one or more food 
establishments in that country, we will: 
  advise the foreign government of our authority under section 807(b) of the FD&C 
Act to refuse admission of a food into the United States if such food is from an 
establishment in a foreign country that the foreign government refuses to  permit 
FDA investigators to inspect; 
  inform the foreign government and the foreign food establishment of our intention 
to list the establishment on the Red List of Import Alert 99-32 based on the 
foreign governments refusal to permit an FDA inspection; and 
  advise the foreign government of the impact of this action (i.e., we may refuse 
entry into the United States for all food from the foreign food establishment until 
an inspection is performed). 
 
  12  Contains Nonbinding Recommendations  
   
 
If the foreign government maintains its refusal after being informed of the consequences, 
we may add each foreign food establishment for which an FDA inspection request was 
refused by the foreign government to the Red List of Import Alert 99-32.  If the foreign 
government sustains its refusal of multiple requests to inspect one or more foreign food 
establishments in the country, we will ask the foreign government if their refusal applies 
to all establishments in their country.  If we determine that the foreign countrys refusals 
apply to all foreign food establishments in the country, we may include all foreign food 
establishments in the foreign country (country-wide) on the Red List of Import Alert 
99-32. 
 
We will advise the foreign government and the foreign food establishment that we will 
consider removing the establishment from the Red List of Import Alert 99-32 when the 
foreign government provides us with written notification that we can inspect the 
establishment (unless the establishment is also on the Red List of Import Alert 99-32 due 
to a refusal of inspection by the owner, operator, or agent in charge of the establishment). 
 
V.  References 
 
FDA Regulatory Procedures Manual.  Chapter 6: Judicial Actions Section 6-3 
Inspection Warrants.  Access online at  
https://www.fda.gov/iceci/compliancemanuals/regulatoryproceduresmanual/ 
 
FDA Import Alert 99-32: Detention Without Physical Examination of Products from 
firms Refusing FDA Foreign Establishment Inspection.  Access online at 
https://www.accessdata.fda.gov/cms_ia/importalert_521.html. 
 
  13