FNC Medical Corporation – FDA 483, Dec 9, 2022

FNC Medical Corporation in Ventura, CA, was inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies in the quality control unit, including inadequate training, failure to follow procedures, poor record-keeping practices, and a lack of proper investigations for out-of-specification results. Additionally, the firm failed to validate test methods, maintain accurate laboratory control records, and ensure proper review of laboratory documentation.