FDA WARNING_LETTER - Triple A Services, Inc. - January 21, 2011

On April 20, 2011, the FDA issued a Warning Letter to Triple A Services, Inc. following an inspection from January 5-21, 2011, at their Chicago, IL facility. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR 110), rendering their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

The FDA cited five primary violations: 1. **Pest Exclusion (21 CFR 110.35(c)):** Failure to effectively exclude pests. Investigators observed birds flying inside, perching above food, and defecating near uncovered food and on carts/crates used for finished products. A cat was also seen inside. The firm's February 8, 2011, response, mentioning an electronic sound device, was deemed inadequate for lacking installation dates and additional comprehensive measures. 2. **Pest Protection (21 CFR 110.20(b)(7)):** Inadequate screening against pests. Open doors, gaps in ceilings (10 ft long, 2.5 inches wide; 6 inches long, 2.5 inches wide), and uncovered dumpsters were observed, allowing pest entry. The response was insufficient, lacking timelines for ceiling repairs. 3. **