FDA EIR - Pharmichem Testing Services Inc - April 03, 2019

An FDA surveillance cGMP inspection of Pharmichem Testing Services Inc., a contract testing laboratory in Tinley Park, IL, took place from March 19 to April 3, 2019. The inspection, conducted under compliance programs for drug manufacturing and API processes, focused primarily on microbiological testing. The main violation, detailed in an FDA Form 483, concerned the firm's failure to thoroughly investigate unexpected discrepancies and out-of-specification (OOS) conditions (21 CFR 211.192). Specifically, investigations into missing or OOS temperature readings from chart recorders for incubators, refrigerators, and freezers were found inadequate. These investigations lacked sufficient evidence to evaluate the potential impact on results from temperature excursions during incubation periods, and implemented corrective actions were ineffective against recurring malfunctions (e.g., battery/power, paper, or ink failures). A separate discussion item highlighted the firm's practice of not performing formal stability studies for in-house prepared media. Pharmichem's management acknowledged both deficiencies and committed to providing a written response with comprehensive corrective and preventative actions. The company agreed to initiate concurrent validation studies for media expiration dating and is considering independent digital temperature data loggers to address the recurring temperature monitoring issues.