FDA 483 - Accu Bio-Chem Laboratories LLC - October 29, 2015

Accu Bio-Chem Laboratories, a contract testing laboratory in Glendale, CA, was cited for significant deficiencies across its laboratory operations and facility maintenance. The inspection revealed issues with computer system controls and validation, inadequate equipment qualification and calibration, incomplete OOS investigations, and deviations in test procedures and record-keeping. Additionally, the facility itself showed poor repair and unsanitary conditions.