FDA WARNING_LETTER - Portsmouth Chowder Co. - August 02, 2013

On July 17-August 2, 2013, the FDA inspected Portsmouth Chowder Company's seafood processing facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, their refrigerated and frozen clam chowder is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

A primary violation is the inadequate HACCP plan for clam chowder, specifically concerning the cook step-lethality critical control point. The plan's monitoring procedures for C. botulinum and pathogenic formation are insufficient. The firm's revised HACCP plan, submitted August 20, 2013, proposes employee monitoring of time-temperature and visual temperature checks, which the FDA states are inadequate. The FDA requires continuous temperature recording devices to ensure critical limits are met, a repeat observation from a previous inspection (December 11, 2012-January 3, 2013). During that prior inspection, the company committed to performing a temperature distribution study for their steam kettles and installing continuous temperature-recording devices, as well as consulting with their filler machine supplier for continuous temperature monitoring during hot filling. This information was not provided during the recent inspection or in their response.

Failure to promptly correct