FDA 483 - DPT Laboratories, Ltd - February 07, 2020

DPT Laboratories, Ltd in San Antonio, TX, a prescription drug manufacturer, was cited with six observations during an FDA inspection. The observations primarily concern deficiencies in the quality control unit's written procedures, review processes, and thoroughness of investigations, as well as issues with laboratory records, test method validation, and master production records. These issues indicate significant gaps in the firm's quality system and control over manufacturing processes.