FDA 483 - Weinert Fiber Optics Inc. - January 13, 2023

Weinert Fiber Optics Inc. in Williamsburg, VA, a manufacturer of fiber optics, was cited for significant deficiencies in its quality system. The inspection revealed inadequate establishment and implementation of corrective and preventive action (CAPA) procedures, including a lack of effectiveness checks and proper handling of open CAPAs. Additionally, the firm failed to submit a Medical Device Report (MDR) within 30 days for a serious injury involving one of its laser fibers.