Sam & Son Wholesale Group, Inc. – FDA Warning Letter, Jun 18, 2012

An FDA inspection of a multiple food storage facility in Atlanta, GA, from June 5-18, 2012, revealed serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 110. These deficiencies, including evidence of rodent activity, render the products adulterated per Section 402(a)(4) of the FD&C Act due to insanitary conditions. Key violations included failure to effectively exclude pests, with observations of rodent gnaw holes, excreta, and live birds. The facility also failed to prevent condensate contamination from fixtures and maintain floors, walls, and ceilings in good repair, showing extensive structural damage, roof leaks, and standing water. Food products were improperly stored, leading to mold, damage, and open exposure. Further issues involved failure to maintain the plant's exterior free of pest attractants, provide adequate pest screening, ensure sanitary employee toilet facilities, use safety lighting over exposed food, and provide sufficient space for sanitary operations. While some corrective actions were initiated during the inspection, a comprehensive written response is required within 15 working days. This response must detail all corrective steps, root cause analysis, completion timelines, and supporting documentation to prevent recurrence. Failure to comply may result in regulatory actions like product seizure or injunctions, and reinspection fees.