FDA EIR - DPT Laboratories, Ltd - February 07, 2020

An FDA pre-approval inspection of DPT Laboratories, Ltd. in San Antonio, TX, was conducted from February 3-7, 2020, to evaluate its readiness for commercial manufacturing of prescription drug products. Operating under current Good Manufacturing Practice (cGMP) regulations, the inspection revealed several deficiencies. Main issues cited in an FDA-483 included the lack of written procedures for the re-integration of HPLC chromatographic peaks for impurities, and the Quality Control Unit's failure to determine the root cause for an unidentified peak found during product testing. Furthermore, method transfer protocols and reports were not approved by Quality Assurance, reference standards used in method validation lacked complete characterization, and a stability-indicating assay for impurities was deemed inadequate. The firm also failed to provide justification for variations in component amounts within master batch records. While management committed to providing written responses to all observations within 15 working days and initiated corrective actions, the site was ultimately determined to be not ready for commercial manufacturing.