FDA 483 - ZOT ENGINEERING LTD - September 07, 2023

ZOT ENGINEERING LTD, a medical device contract manufacturer in Musselburgh, United Kingdom, received a Form FDA 483 citing significant deficiencies across its quality system. The inspection revealed inadequate complaint handling procedures, including a failure to evaluate complaints for Medical Device Reporting (MDR) and misclassifying customer events. Additionally, the firm failed to adequately validate manufacturing processes and third-party software applications, and its document control procedures were found to be non-compliant.