FDA 483 - Focus Scientific Services - December 16, 2022

Focus Scientific Services, a control testing laboratory in Palm Harbor, FL, received a Form 483 for failing to follow established test procedures and laboratory control mechanisms. The inspection revealed deficiencies including not confirming atypical microbiological growth, a technician not adhering to aseptic technique by failing to change gloves, and a lack of proper installation and operational qualification documentation for laboratory equipment like a laminar flow hood. These findings indicate significant non-compliance with internal protocols and quality control standards.