FDA 483 - Gulf Fiberoptics, Inc. - March 23, 2023

Gulf Fiberoptics, Inc. in Oldsmar, FL, a manufacturer of Class II endoscopic fiber optic cables and headlights, was inspected by the FDA. The inspection revealed two significant issues related to quality system documentation. Specifically, the firm failed to adequately document corrective and preventive action activities and did not properly maintain its device master record.