FDA 483 - Microbac Laboratories, Inc. - May 24, 2021

An FDA inspection of Microbac Laboratories, Inc. in Sterling, VA, a contract testing laboratory, revealed significant deficiencies in their quality control unit. The firm failed to adequately document responsibilities and procedures, secure master files, and ensure proper quality review and signatures for out-of-specification reports and calibration documents. These issues indicate a lack of robust quality system controls.