FDA WARNING_LETTER - Nathan's Soup & Salad Henrietta Inc. - August 25, 2017

The FDA inspected Nathan's Soup and Salad Henrietta Inc.'s facility from August 21-25, 2017, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's refrigerated New England Clam Chowder was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because it was prepared, packed, or held under insanitary conditions.

The primary violation cited was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for its refrigerated New England Clam Chowder, as required by 21 CFR 123.6(a) and (b). This omission means the firm lacks controls for food safety hazards such as pathogen growth, pathogen survival through cooking/pasteurization, and toxin formation, including Clostridium botulinum, due to time/temperature abuse.

The FDA requires the firm to take prompt action to correct these violations. Failure to comply may result in regulatory actions, including seizure and injunction. The FDA also noted that re-inspection fees may be assessed to cover costs related to verifying compliance. The firm must respond in writing within fifteen working days, detailing the specific corrective steps taken, including documentation, or provide a reason for delay and a timeline for completion.