# FDA WARNING_LETTER - Millington Seafood LLC - August 29, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/millington-seafood-llc/790623a6-e575-44db-be1d-7bc33775e78d

> FDA WARNING_LETTER for Millington Seafood LLC on August 29, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Millington Seafood LLC
- Inspection Date: 2012-08-29
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: On October 3, 2012, the FDA issued a Warning Letter to Millington Seafood, LLC, following an inspection from August 22, 27, and 29, 2012, at their facility in Millington, MD. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their histamine and non-histamine forming finfish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
- Lack of a written HACCP plan for histamine and non-histamine forming (b)(4) [21 CFR 123.6(b)].
- HACCP plan for (b)(4) does not list associated food safety hazards [21 CFR 123.6(c)(1)].
- HACCP plan for (b)(4) lists a critical limit insufficient to control hazards [21 CFR 123.6(c)(3)].
- Failure to review critical control point monitoring records for (b)(4) within one week [21 CFR 123.8(a)(3)].
- Insufficient frequency in monitoring sanitation conditions and practices to ensure CGMPs [21 CFR 123.44(b)].
- Failure to maintain sanitation control records

## Related Officers

- [District Director](https://www.globalkeysolutions.net/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)

Company: https://www.globalkeysolutions.net/companies/millington-seafood-llc/99f5d29e-1434-43b4-af0b-bf0a32ef8b1c

Office: https://www.globalkeysolutions.net/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861