# FDA WARNING_LETTER - Macduff Shellfish (Scotland) Ltd - December 06, 2019

Source: https://www.globalkeysolutions.net/records/warning_letter/macduff-shellfish-scotland-ltd/8f483400-c16b-49f9-af0a-c09ca90cc7ba

> FDA WARNING_LETTER for Macduff Shellfish (Scotland) Ltd on December 06, 2019. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Macduff Shellfish (Scotland) Ltd
- Inspection Date: 2019-12-06
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On April 3, 2020, the FDA issued a Warning Letter to Macduff Shellfish (Scotland) Ltd following an inspection on December 5-6, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's ready-to-eat (RTE) frozen cooked rock crab and ready-to-cook frozen lobster products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include:
1.  **Inadequate Hazard Analysis:** The HACCP plan for RTE frozen cooked rock crab did not list *Clostridium botulinum* toxin formation as a hazard, despite the product being in packaging conducive to its growth. The HACCP plan for ready-to-cook whole frozen lobster products failed to list undeclared major food allergens/intolerance substances (e.g., sulfites), which are used in processing. The firm's February 3, 2020 response was inadequate as it did not address these hazards in the HACCP plans.
2.  **Failure to Take Appropriate Corrective Action:** The firm did not take corrective action when the "Whole Brown Crab – Cooked Frozen" process deviated from the critical limit for pathogenic bacteria control. A production record showed the internal temperature of a crab reached only (b

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.globalkeysolutions.net/companies/macduff-shellfish-scotland-ltd/01bb25ea-5a32-4292-9d06-7894713cdcbd

Office: https://www.globalkeysolutions.net/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2