FDA 483 - PTI Georgia, LLC - January 16, 2026

PTI Georgia, LLC dba Pharma Tech Industries, a contract manufacturer in Royston, GA, was cited for significant deficiencies across its laboratory, production, and quality systems during an FDA inspection. Observations include inadequate control over specifications and electronic records, insufficient record retention, failure to establish robust production procedures, and deficiencies in discrepancy investigations and equipment maintenance. These issues indicate systemic problems in maintaining cGMP compliance.