FDA 483 - Dr. Mach Gmbh & Co. KG - July 28, 2022

Dr. Mach Gmbh & Co. KG, a medical device manufacturer in Ebersberg, Bavaria, Germany, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in their quality system, including inadequate corrective and preventive actions, insufficient production process controls, incomplete process validation, and deficient device history records. Additionally, the firm failed to implement Unique Device Identifier (UDI) labeling for products shipped to the United States.