Description
The purpose of this document is to provide guidance for FDA staff on FDA’s direct reference enforcement policy on decomposition in fish and fishery products.
Scope & Applicability
Product Classes
1Fish 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
1Qualified FDA seafood sensory analysts
Personnel authorized to determine decomposition
Regulatory Context
Attributes
125 micrograms indole per 100 grams
Action level for indole in shrimp products
Identified Hazards
Hazards
1Decomposition
A condition leading to the appearance of adulteration.
Related Warning Letters (1)
- 2022-09-13
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Chaur Fong Inc. dba 888 Food Company
See Also (8)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (Status: Final)
- Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (Status: Final)
- Guía para la industria: Evaluación de la inocuidad de los cultivos alimentarios para el consumo humano afectados por las inundaciones (Status: Final)