Andersen America, Inc. – FDA Warning Letter, Jun 29, 2012

On October 22, 2012, the FDA issued a Warning Letter to Andersen America, Inc. following an inspection of their seafood processing facility in Hayward, California, from June 19 to June 29, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation was the firm's failure to have and implement a written HACCP plan for their ready-to-eat, vacuum-packaged tuna salad product, which is distributed wholesale, to control hazards such as histamine and Clostridium botulinum toxin formation, as required by 21 CFR 123.6(a) and (b). This renders the product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Additionally, the firm failed to maintain sanitation control records for critical areas including water safety, food contact surfaces, cross-contamination prevention, hand-washing facilities, protection from adulterants, toxic compound management, employee health, and pest exclusion, violating 21 CFR 123.11(c).

The FDA warned that failure to promptly correct these violations could lead to further action, including product seizure and injunctions. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including submission of HACCP and sanitation monitoring records