DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

FDA’s Sentinel of Public Health:

Field Staff Safeguards High Standards

As an agency that protects the

health of all Americans, the FDA

must keep in touch with consumers and firms dealing with

regulated products all over the

United States. Regulating almost

124,000 business establishments

that annually produce, warehouse,

import and transport $1 trillion

worth of consumer goods is no

small task. The FDA devotes to

this crucial task, which is directed

by the Office of Regulatory

Affairs (ORA), about one-third of

the agency’s personnel. Stationed

in more than 160 offices, resident

posts and laboratories from coast

to coast and in Puerto Rico, ORA’s

highly trained staff provides the

eyes, ears and the long arm of the

agency that ensures the

implementation of the FDA’s high

public health standards. Here are

some of the major activities of

ORA specialists:

• Consumer safety officers

(CSOs) and inspectors conduct

about 22,000 domestic and foreign

inspections a year to ensure that

regulated products destined for the

U.S. market meet the agency’s

standards. Plants are inspected

both before the FDA approves a

product, to make sure that the firm

has the capacity for high-quality

production, and periodically afterwards, to ascertain that it follows

appropriate manufacturing processes. CSOs also monitor clinical

trials that are conducted before the

products are submitted to the FDA

for approval.

• Scientists in ORA’s 13 laboratories analyze more than 41,000

product samples each year to determine their adherence to the

FDA’s standards. The analyzed

products include samples of the

9.3 million import shipments that

are overseen

by ORA inspectors in

the nation’s

ports of entry. Imported

products that

do not measure up to

FDA standards are not

allowed on

the U.S. market.

• Public affairs specialists reach

out to consumer groups, health

care professionals, and state health

authorities to explain FDA policies and encourage compliance

with FDA standards. In addition to

briefing interested groups and responding to press inquiries, these

specialists work together with the

rest of the field staff to rapidly respond to public health emergencies caused by natural disasters

and product problems.

For more information, please

call ORA at 301-827-3101 or visit

the FDA Web site at www.fda.gov/

ora.

Kansas City

Los Angeles

Boston

New York

New Jersey

Philadelphia

Baltimore

New Orleans

Florida

San Juan

Chicago

Atlanta

Cincinnati

Minneapolis

Detroit

Denver

Dallas

Seattle

San Francisco

Alaska is in the Seattle District,

Hawaii, Guam and American Samoa are in the

San Francisco District, 

U.S. Virgin Islands are in the San Juan District.

ORA’s Regional and District Offices

Publication No. FS 01-7

FDA Web site: www.fda.gov

12/03

ORA’s Increased Strength

The FDA’s ability to protect the

public health has been enhanced by

additional resources authorized by

Congress in the wake of the Sept.

11, 2001, terrorist attacks. The FDA

hired 655 new ORA employees, 600

of whom strengthen food safety, 35

enhance the safety of animal drugs

and feed, and 20 are part of the drug,

biologic and device programs.

About 420 of the new inspectors and

other employees either are stationed

at border locations or are working

specifically on imports. All of the

new hires will be trained in both

import and domestic operations to

help ensure adequate coverage of

both domestically manufactured and

imported products.