FDA 483 - 3D Medical Manufacturing, Inc. - September 15, 2022

During an inspection conducted from September 12-15, 2022, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to 3D Medical Manufacturing, Inc., a medical device manufacturer located in Pennsauken, NJ. The inspection revealed an observation concerning the company's quality system, specifically regarding documentation of complaint investigations. The FDA noted that records of complaint investigations did not include all required information. One particular complaint report, related to laser markings, failed to identify both the incorrect lot number involved and the new lot number used to correct the problem. This observation indicates a deficiency in maintaining complete complaint investigation records, which is crucial for compliance with the Federal Food, Drug, and Cosmetic Act's regulations for medical device quality systems. 3D Medical Manufacturing, Inc. is now responsible for conducting internal self-audits to identify and correct all violations of quality system requirements, implementing comprehensive corrective actions to address this observation, and providing a timely response to the FDA outlining its plans to rectify these deficiencies and ensure full adherence to regulatory standards.