FDA WARNING_LETTER - Ocean Pier, Inc. - June 26, 2012

On June 25-26, 2012, the FDA inspected Ocean Pier, Inc.'s seafood processing facility in Scoudouc, New Brunswick, Canada, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's August 7, 2012, response to the FDA-483 was deemed inadequate.

The FDA found that Ocean Pier's frozen vacuum-packaged crab cakes and vacuum-packaged crab Rangoon were adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Specific deficiencies in their revised HACCP plans included:

1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** * Non Fried Crab Cakes HACCP plan failed to list undeclared allergens, *Staphylococcus aureus* growth and toxin formation during processing/handling, and *Clostridium botulinum* growth and toxin formation in finished packaged product. * Crab Rangoon HACCP plan failed to list undeclared allergens.

2. **Missing Critical Limits (21 CFR 123.6(c)(3)):** * Non Fried Crab Cakes HACCP plan lacked a critical limit for ambient thawing temperature at the "Step #6: