Ajinomoto Althea, Inc. – FDA 483, Feb 10, 2012

During an inspection conducted from February 6-10, 2012, DPT Laboratories, Ltd., a drug manufacturer in San Antonio, TX, received an FDA Form 483 citing several significant observations related to their manufacturing and quality control processes. The inspection identified four primary issues, several of which were repeat observations from previous inspections.

Key violations included deficiencies in laboratory record-keeping, specifically the invalidation of Out-of-Specification (OOS) assay results for a topical solution without a complete investigation or adherence to established procedures. Furthermore, the quality control unit failed to adequately follow its responsibilities, evidenced by Annual Product Reviews not detecting that bulk product testing for viscosity and specific gravity had not been performed prior to release.

The inspection also noted inadequate control procedures for monitoring manufacturing processes, as critical quality attributes like viscosity and specific gravity were omitted from the process performance qualification for a topical solution. Finally, laboratory controls were found lacking due to unvalidated and improperly executed test procedures for "Viscosity for Liquids, Gels, and Suspensions," resulting in inaccurate data on Certificates of Analysis. These issues indicate a need for enhanced adherence to Current Good Manufacturing Practice (CGMP) regulations. DPT Laboratories is expected to respond to these observations by implementing comprehensive corrective actions to ensure compliance and product quality.