FDA 483 - Contract Medical International GmbH - May 11, 2023

During an inspection conducted from May 8-11, 2023, the FDA issued a Form FDA-483 to Contract Medical International GmbH, a Class II medical device manufacturer located in Dresden, Saxony, Germany. The primary observation noted was the inadequate establishment of procedures for the acceptance and control of in-process products. Specifically, the company's Quality Control Inspection procedure (SOP-QA-002) and its associated Work Instruction (HMDD-0028-WI-0002) were found to lack adequate detail or implementation regarding inspection data collection. This indicates a deviation from the quality system requirements as outlined under the Federal Food, Drug, and Cosmetic Act. While the FDA-483 is an observation, not a final determination, Contract Medical International GmbH is responsible for promptly evaluating these deficiencies, implementing robust corrective actions, and ensuring their quality system fully complies with regulatory standards to prevent recurrence and maintain product integrity.