Imports and Inspections
International Regulatory Activities
FDA is a scientifically based regulatory agency, and the Office
of Regulatory Affairs (ORA) is the agency's enforcement arm. ORA's mission
is twofold: to safeguard the public health and to ensure honesty and fair
dealing between the regulated industry and consumers. ORA achieves its mission
by:
- participating in cooperative and educational efforts at home and abroad
to inform those who need to know of the agency's legal requirements;
- surveying and inspecting regulated industry to assess compliance and implement
corrective measures as warranted to achieve compliance; and
- seeking to deter fraud, intentional violations, and gross negligence related
to FDA- regulated products.
ORA has the lead on international enforcement issues such as imports and foreign
inspections. The Office ensures that products imported to the United States
and regulated by the agency meet the same safety, efficacy and quality standards
as those products manufactured domestically. ORA is also involved in assuring
conformance with Memoranda of Understanding (MOUs) with foreign countries and
plays a pivotal role in ensuring that MOUs strengthen compliance. In addition,
ORA collaborates with the Office of International Affairs to meet the needs
of foreign visitors who wish to learn about FDA and regulated industry in field
locations.
FREQUENTLY ASKED QUESTIONS:
- What laws, regulations and policies apply to imported products? What's
going to happen to my products when they reach the United States? Will they
be sampled? What do I do if they are detained? How does a firm get removed
from "detention without physical examination?" How can my firm
respond to a "country-wide detention without physical examination?"
For procedural questions such as these, as well as updates on import
policy and programs, check the import
program or call the Division of Import Operations and Policy (DIOP),
301-443-6553; FAX: 301-594-0413.
- Why is my shipment of canned food being detained and why are my
products sampled so much?
Inquiries on specific shipments should be directed to the FDA District
Import Program Manager near the point of entry. You will need
to know the Customs Entry Number and the FDA Sample Number.
- When will my (overseas) plant be inspected? Can you help me
understand what I need to do to respond to the FDA-483 I received?
For inquiries regarding inspections,
contact the Division of Field Investigations at 301-827-5653,
FAX: 301-443-3757; ask for the Consumer Safety Officer responsible
for the product area, e.g., drugs or devices.
INTERNATIONAL REGULATORY RESOURCES
General import requirements
and guidance, including import
alert documents and import detention
reports, are now available. Industry, trade associations, embassies,
and consumers can access this information without contacting FDA staff.
Publications - Compliance Policy Guides
(CPG) - this publication provides statements of FDA compliance policy,
including regulatory action guidance.
Other Agency - Customs and Border Protection provides
specific information on customs requirements and procedures, and can be contacted
at 202-927-5580; FAX: 202-927-1393.
