FDA WARNING_LETTER - Nautical Foods, LLC - March 28, 2017

Record Details

On February 28, 2017, through March 28, 2017, the FDA inspected Nautical Foods, LLC, located in Secaucus, New Jersey. Environmental samples collected during the inspection tested positive for *Listeria monocytogenes* (L. monocytogenes) in areas where ready-to-eat seafood salads are manufactured and packaged, including the packaging area and ready-to-eat kitchen. Whole Genome Sequence (WGS) analysis revealed a resident strain of *L. monocytogenes* present since at least January 2016, indicating inadequate sanitation.

The FDA determined that the firm's ready-to-eat (RTE) seafood products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) were identified.

Specific HACCP violations include: 1. Failure to list a critical control point for time temperature indicators (TTIs) in the "Crab Cake & Crab Cake Mix" HACCP plan to control *Clostridium botulinum* growth. 2. Inadequate critical limits for undeclared allergens and sulfites in "Crab Cake & Crab Cake Mix," "RTC Frozen Product other than Crab Cake," and "RTE Seafood Salad"

Company: Nautical Foods, LLC
Inspection Date: March 28, 2017
Product Type: Food
Office: Baltimore District Office
Person: Evelyn Bonnin (District Director)

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ID · 2d8756e2-822a-4e59-88a3-bc2a2e13f2bb

Violation Codes9

21 U.S.C. 342(a)(4)21 CFR 123.6(a)21 CFR 123.6(c)(2)21 CFR 123.6(c)(3)21 CFR 123.6(c)(4)21 CFR 123.6(b)21 CFR 123.6(c)(7)21 CFR 123.7(b)21 U.S.C. 379j-31(a)(2)(B)

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