Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products | Guideline Explorer

Description

This guidance represents the FDA's current thinking on refusal of inspection or access to HACCP records pertaining to the safe and sanitary processing of fish and fishery products. It does not create or confer any rights for or on any person, nor does it operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. This guidance is being issued in accordance with FDA's Good Guidance Practices (65 FR 56468; September 19, 2000).

Scope & Applicability

Product Classes

3

Acidified foods

Records for these products are reviewed independently of visual inspection.

Low-acid canned foods

environment supporting C. botulinum growth if inadequately processed; This chapter does not address heat treatments that lead to commercial sterility of low-acid canned foods.; commonly called LACF, subject to 21 CFR part 113; Thermally processed foods in hermetically sealed containers

Fish and Fishery Products

The primary product category covered by the sampling recommendations.; Products subject to detention without physical examination; Subject to detention without physical examination (DWPE)

Stakeholders

3

importers

Entities required to comply with requirements for imported seafood products

Importer

Must comply with registration if meeting facility/responsible person definitions

Processor

An establishment that performs processing steps on ACTPs.

Related CFR Sections (4)

21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
21CFR123.3§ 123.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms where suRead full regulation →
21CFR123.6§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
(a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that thRead full regulation →
21CFR123.9§ 123.9 Records.
(a) General requirements. All records required by this part shall include:Read full regulation →

Related Warning Letters (10)

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
2025-12-16
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
2025-09-30
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated
Rey de los Camarones S. A.
2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Reunipeche SAS
2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yeshua Bendito, C.A.
2025-05-20
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Eden F&C Co., Ltd
2025-05-20
Seafood HACCP/CGMP for Foods/Adulterated
Mariscos Procesados - CAMPRESA - S.A.
2025-03-04
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
COFISA - Conservas de Peixe da Figueira, S.A.
2025-01-21