FDA WARNING_LETTER - NY Fish, Inc. - November 03, 2009

The FDA inspected NY Fish Inc. from October 20 to November 3, 2009, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. Environmental swabs tested positive for *Listeria monocytogenes* (L. mono), leading to adulterated ready-to-eat cured and smoked fish products under 21 U.S.C. §342(a)(4). This is a repeat finding, with L. mono detected in previous inspections (May-June 2009: 60 positive swabs; September 2008: 10 positive swabs), and finished product samples testing positive.

Additionally, the firm improperly used an antimicrobial solution, (b)(4), directly in brining, on in-process seafood, and on packaging, causing adulteration under 402(a)(2)(c) as it's not approved for seafood use (21 CFR §§ 173.370, 173.315).

Specific HACCP and GMP violations include: 1. Failure to implement monitoring procedures for "Storage of finished product" critical control point (CCP), specifically continuous temperature monitoring. 2. Failure to record monitoring observations for "Receiving Scombroid Sp." and "Fish with the hazard of parasites and to be