FDA WARNING_LETTER - Wannemacher Enterprises Inc - April 17, 2012

On June 1, 2012, the FDA issued a Warning Letter to Wannemacher Enterprises following an inspection of their seafood processing facility in Upper Sandusky, OH, from March 28 to April 17, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their spray-dried seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - Failure to list finished product labeling as a critical control point for allergen control in the HACCP plan for spray-dried seafood products (21 CFR 123.6(a) and (c)(2)). - Failure to list the monitoring frequency at the drying critical control point to control pathogen growth and toxin formation in the HACCP plan for dried seafood products (21 CFR 123.6(c)(4)). - Inappropriate corrective action plan for dried seafood products at the drying critical control point, as it does not assure affected product does not enter commerce and the cause of deviation is corrected (21 CFR 123.7(b)).

The firm's April 25, 2012, response was deemed inadequate as the significant violations remained uncorrected. The FDA requires prompt corrective action to comply with the Act, seafood