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

Source: https://www.globalkeysolutions.net/records/warning_letter/nautical-foods-llc/2d8756e2-822a-4e59-88a3-bc2a2e13f2bb

> FDA WARNING_LETTER for Nautical Foods, LLC on March 28, 2017. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nautical Foods, LLC
- Inspection Date: 2017-03-28
- Product Type: Food
- Office Name: Baltimore District Office
- Summary: 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"

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/nautical-foods-llc/725fefc1-99a4-4f35-96dc-42088c2672ee

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa