FDA WARNING_LETTER - Mom's Food Products, Inc. - July 29, 2010

On July 20-29, 2010, the FDA inspected Mom's Food Products, Inc. in Ft. Worth, Texas, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render their tuna salad sandwiches adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan:** The "HCCP PLAN TUNA FISH SANDWICH" failed to list critical food safety hazards: Clostridium botulinum growth and toxin formation (due to modified/reduced oxygen packaging), undeclared allergens (fish, wheat, soy, eggs, milk), and histamines. The firm's proposed new packaging film still inhibits safe oxygen transmission. 2. **Failure to Take Corrective Action:** The firm did not take corrective action when a cooler storing tuna salad and finished products exceeded the critical limit of (b)(4) °F on May 5, 2010, failing to prevent pathogen growth or interstate distribution of affected product. 3. **Insufficient Sanitation Monitoring:** The firm did not adequately monitor sanitation conditions. Observations included an employee conducting pre-operational sanitation without handwashing, touching food contact surfaces without gloves, incorrect sanitizer concentration ((