FDA 483 - Hmt Medizintechnik Gmbh - June 22, 2023

During an FDA inspection conducted from June 19-22, 2023, Hmt Medizintechnik Gmbh, a medical device and contract manufacturer in Maisach, Germany, received a Form FDA-483 detailing significant observations regarding its quality system. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, identified three main deficiencies requiring action.

First, the company did not fully document rework and reevaluation activities within device history records. A specific example involved product rework due to incorrect assembly, where neither the rework nor subsequent reinspection was recorded in the device history or nonconformance records.

Second, corrective and preventive action (CAPA) activities and their results were inadequately documented. Several CAPA investigations lacked documented rationales for their scope, evidence of implementation, or comprehensive root cause determinations, as seen with issues like expired calibration equipment and product complaints.

Finally, Hmt Medizintechnik Gmbh failed to adequately validate a critical process. The sterilization validation had not been renewed since January 2016, despite the company's own procedures requiring periodic revalidation. The firm is now responsible for addressing these observations and implementing corrective actions to ensure full compliance with quality system requirements.