# FDA WARNING_LETTER - Josephson's Smokehouse - December 02, 2013

Source: https://www.keypedia.com/records/warning_letter/josephsons-smokehouse/9d8a67c0-2237-4dc2-9c18-6a7b365214a2

> FDA WARNING_LETTER for Josephson's Smokehouse on December 02, 2013. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Josephson's Smokehouse
- Inspection Date: 2013-12-02
- Product Type: Food
- Office Name: Seattle District Office
- Summary: The FDA inspected a seafood processing facility in Astoria, Oregon, from November 18-22, 2013, with follow-up visits from November 27-December 2, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering vacuum-packaged, hot-smoked fish products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, product labeling caused misbranding under 21 U.S.C. § 343(a)(1).

The firm's December 8, 2013, response to the FDA 483 was partially adequate, lacking sufficient evidence of implemented corrections. Key HACCP violations included:
1.  Failure to list marinating as a critical control point for pathogen (Staphylococcus aureus) growth and toxin formation in the vacuum-packaged, hot-smoked fish HACCP plan, despite extended marinating times.
2.  Absence of critical limits in the HACCP plan for:
    *   Temperature control during extended brining (up to 24 hours) to prevent pathogen growth (Staphylococcus aureus) and histamine formation in scombroid species.
    *   Brining parameters (fish species, portion size) to ensure adequate water phase salt

## Related Officers

- [Ann M. Adams](https://www.keypedia.com/people/ann-m-adams/a6ac6fe8-f6b8-488a-9d36-bb32df0916bd)

Company: https://www.keypedia.com/companies/josephsons-smokehouse/ab369f16-85ed-49ab-8487-6c0dd9dfd187

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913