483
Focus Scientific ServicesFDA 483 - Focus Scientific Services - December 16, 2022
Record Details
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.
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ID · 662b4e85-0771-4a2c-a8f4-2ca23183688d