# FDA WARNING_LETTER - G.N.Y. Filet Fish Co., Inc. - August 29, 2008

Source: https://www.keypedia.com/records/warning_letter/gny-filet-fish-co-inc/78c6f4af-e7b7-44a2-98a9-c2a01e9f3310

> FDA WARNING_LETTER for G.N.Y. Filet Fish Co., Inc. on August 29, 2008. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: G.N.Y. Filet Fish Co., Inc.
- Inspection Date: 2008-08-29
- Product Type: Food
- Office Name: New York District Office
- Summary: On August 28 and 29, 2008, the FDA inspected G.N.Y. Filet Fish Co., Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110). These violations render the firm's bluefish and imported turbot adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific violations include:
1.  Failure to implement the record-keeping system for monitoring observations at the "Receiving" and "Storage" critical control points to control histamine in bluefish, as required by 21 CFR 123.6(b) and (c)(7).
2.  Failure to implement an affirmative step to ensure imported turbot filets from [(b)(4)] were processed in accordance with seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

The FDA warns that failure to promptly correct these violations may result in refusal of admission for imported fish products, detention without physical examination, product seizure, and/or injunction. The firm must respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as HACCP and importer verification records. The letter emphasizes the firm's responsibility to ensure compliance

## Related Officers

- [Otto D. Vitillo](https://www.keypedia.com/people/otto-d-vitillo/362f7863-2591-40bd-8680-b59819da4798)

Company: https://www.keypedia.com/companies/gny-filet-fish-co-inc/d53fddb4-0d44-487a-a1dc-c43a91d1d113

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d