FDA WARNING_LETTER - Simmons Pet Food, Inc. - February 15, 2008

On February 14-15, 2008, the FDA inspected Simmons Pet Food, Inc.'s low-acid canned pet food facility in Siloam Springs, Arkansas, finding serious deviations from 21 CFR Part 108 and Part 113. These violations render products adulterated under section 402(a)(4) of the Act.

Key violations include: 1. **Lack of Product Traffic Control (21 CFR 113.87(b)):** Retort doors can open simultaneously, allowing unprocessed cans to bypass the retort. The firm's response to reprogram retorts is incomplete as it doesn't address non-run mode scenarios. 2. **Inadequate Container Cooling Water Sanitation (21 CFR 113.60(b)):** Cooling canal water lacked measurable chlorine. The firm's plan to create a new SOP and relocate a chlorine pump is incomplete, failing to address affected product. 3. **Failure to Record Process Deviations (21 CFR 113.89):** A temperature drop on February 12, 2008, was not properly identified or addressed. The firm's retraining plan is incomplete, lacking actions for the affected product. 4. **Inadequate Record Review (21 CFR 113.100(b) and (c)):** Thermometer validation