Mid South Produce Distributors, LLC – FDA Warning Letter, Feb 19, 2010

On February 8-19, 2010, the FDA inspected Mid South Produce Distributors, LLC's food processing and storage facility in Nashville, Tennessee. The inspection revealed serious violations of 21 CFR Part 110, Current Good Manufacturing Practice (CGMP) regulations, leading to adulterated food under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Specific violations included: 1. Failure to exclude pests from food storage areas (21 CFR 110.35(c)): Hundreds of rodent pellets, gnawed produce, rodent gnawed holes, and millipedes were found in various storage areas and on the loading dock. 2. Failure to provide adequate pest protection (21 CFR 110.20(b)(7)): Broken windows and roof openings in the dry storage room allowed pests easy access.

The FDA acknowledged prompt corrective actions taken during the inspection, including building renovations, cleaning, and voluntary destruction of adulterated food. However, Mid South Produce Distributors, LLC is required to provide written notification within fifteen working days of receiving the letter, detailing specific steps taken to prevent recurrence of violations, including documentation and a timeframe for any additional planned corrections. The response should be sent to Kari L. Batey, Compliance Officer.