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

An FDA inspection of Accu Bio-Chem Laboratories, LLC, a contract testing laboratory for topical drug and cosmetic products in Glendale, CA, was conducted from October 26-29, 2015. The inspection, carried out under drug manufacturing inspection guidelines (CP 7356.002), focused on the firm's Quality, Facilities and Equipment, and Laboratory Controls Systems. The inspection revealed significant violations of regulatory standards, leading to the issuance of a Form FDA 483 with eleven observations. Primary issues included a lack of appropriate controls over computer systems and data integrity, specifically the manual manipulation of HPLC chromatograms without objective criteria or audit trails, indicating a risk to data reliability. The firm also failed to routinely qualify and calibrate critical analytical equipment like HPLCs, analytical balances, stability chambers, and laminar flow hoods, with instances of uninvestigated out-of-specification results and incomplete documentation. Further deficiencies involved inadequate written procedures for investigating out-of-specification results, reviewing complaints and product evaluations, and documenting method modifications. Facility conditions were also cited, including buildings not maintained in good repair (e.g., clutter, direct openings to the outside) and unsanitary conditions, particularly in the microbiology laboratory. Accu Bio-Chem Laboratories, LLC was required to submit a written response to the FDA addressing these observations, outlining corrective actions to ensure compliance with Current Good Manufacturing Practices (cGMP) for drug manufacturing. This indicates a need for comprehensive improvements across quality, laboratory, and facility management systems.