FDA 483 - Pro-Tech Design & Mfg. Inc. - June 27, 2025

Pro-Tech Design & Manufacturing, Inc. in Santa Fe Springs, CA, was inspected by the FDA from June 23-27, 2025. The inspection revealed a significant quality system deficiency concerning the lack of validation for the re-boxing process of sterile medical devices. This indicates a failure to ensure that processes whose results cannot be fully verified by subsequent inspection and test are properly validated.