FDA 483 - Accu Bio-Chem Laboratories LLC - August 31, 2021

Accu Bio-Chem Laboratories, a contract testing laboratory in Glendale, CA, was cited for significant deficiencies during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results for OTC drug products, lacked appropriate computer controls to prevent data deletion, and did not ensure laboratory records were reviewed for accuracy and completeness. Additionally, the verification of analytical and microbiology testing methods for OTC drug products was found to be inadequate.