FDA WARNING_LETTER - Vendors Unlimited Corporation - November 08, 2013

The FDA inspected Vendors Unlimited Corporation's food processing facility in Dubuque, IA, from October 29 to November 8, 2013. The inspection revealed serious violations of Current Good Manufacturing Procedures (CGMP) for Human Food (21 CFR Part 110), causing food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations included: 1. **Failure to adequately use sanitizing agents (21 CFR 110.35(d)(5))**: A sanitizing agent's concentration was found to be (b)(4) ppm, below the directed range of (b)(4) - (b)(4) ppm. 2. **Failure to conform to hygienic practices (21 CFR 110.10(b))**: Employees handled ready-to-eat sandwich components and food contact surfaces (e.g., non-sanitized trays) with bare hands after cleaning activities without washing, and used a gloved hand to pick up a knife from the floor and continued food preparation without changing gloves or cleaning hands.

The FDA warned of potential further action, including product seizure and injunctions. The company was required to respond in writing within fifteen working days, outlining specific corrective actions and providing supporting documentation. Failure to correct violations could result in FDA assessing fees for reinspection-related costs.