Description
The document provides guidance related to the FDA’s regulatory oversight activities for food products covered by a Systems Recognition Arrangement (SRA) between another country’s food safety authority and FDA.
Scope & Applicability
Product Classes
3importers of fish and fishery products
Subject to specific HACCP and FSVP exemptions.
Product category subject to refusal of admission
Stakeholders
1Regulatory counterpart in another country; FDA will ensure prompt notification of a food safety concern to the foreign competent authority
Identified Hazards
Hazards
2notification of a food safety concern to the foreign competent authority
Misinformation about medical products treating serious diseases
Related CFR Sections (3)
- 21CFR123.12§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.Read full regulation →
- 21CFR120.14§ 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.Read full regulation →
- 21CFR1.513§ 1.513 What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?
(a) General.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-18
Foreign Supplier Verification Program (FSVP)
Ocho Rios Atlanta Inc.
- 2025-11-04
Foreign Supplier Verification Program (FSVP)
East Bay Wholesale Corporation
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Adja Khady Food Distribution Inc
- 2025-10-07
Foreign Supplier Verification Program (FSVP)
Life Wholesale
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Delicias Del Country USA Inc
- 2025-09-30
Foreign Supplier Verification Program (FSVP)
Ever Rich Foods LLC
- 2025-09-16
Foreign Supplier Verification Program (FSVP)
DingMoo LLC DBA Dingman’s Dairy
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
See Also (8)
- Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products (Status: Final)
- Guidance for Industry: Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals (Status: Final)
- Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Guidance for Industry: FDA's Voluntary Qualified Importer Program (Status: Final)
- Small Entity Compliance Guide: Juice HACCP (Status: Final)
- Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Questions and Answers on the Accredited Third-Party Certification Program (Status: Draft)