Description
This document is intended to provide guidance. It represents the Agency's current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Scope & Applicability
Product Classes
1The primary product category covered by the sampling recommendations.; Products subject to detention without physical examination; Subject to detention without physical examination (DWPE)
Stakeholders
2Specific processes found on the GRP website
An establishment that performs processing steps on ACTPs.
Identified Hazards
Hazards
1Issues bearing on hazards reasonably likely to occur
Related CFR Sections (2)
- 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 →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Rey de los Camarones S. A.
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Reunipeche SAS
- 2025-05-20
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
- 2025-03-04
Seafood HACCP/CGMP for Foods/Adulterated
Mariscos Procesados - CAMPRESA - S.A.
- 2025-01-21
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
COFISA - Conservas de Peixe da Figueira, S.A.
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)