Fiberoptic Technology, Inc. – FDA 483, Jul 24, 2026

An FDA inspection of Fiberoptics Technology, Inc. in Pomfret, CT, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately document design changes, risk management processes, supplier qualifications, and complaint handling procedures. Additionally, issues were noted with product safety testing records and unique device identification traceability, indicating a lack of control over critical manufacturing and quality processes.