FDA 483 - Accu Bio-Chem Laboratories LLC - February 08, 2023

An FDA inspection of Accu Bio-Chem Laboratories LLC, a contract testing laboratory in Glendale, CA, revealed significant deficiencies in their quality control unit and equipment management. The firm failed to adequately document out-of-specification results, conduct proper management reviews, and maintain complete written procedures for various quality activities. Additionally, the inspection found a lack of appropriate design and documentation for equipment qualification, specifically for a spectrophotometer system.