FDA 483 - A.M. Surgical, Inc. - October 20, 2023

From October 17 to October 20, 2023, the U.S. Food and Drug Administration (FDA) conducted an inspection of A.M. Surgical, Inc., a medical device manufacturer based in Smithtown, NY. Following the inspection, the company received a Form FDA 483, detailing an observation of concern. The primary issue identified was that the firm's device master record, a critical component of regulatory compliance for medical device manufacturing, was not adequately maintained. Specifically, the documentation failed to properly identify the materials used in the manufacturing of their medical devices. This observation highlights a deficiency in adhering to the quality system requirements mandated by the Federal Food, Drug, and Cosmetic Act. Adequate documentation, including material identification, is crucial for ensuring product quality, safety, and traceability. The FDA 483 serves as a formal notification of these inspectional observations and is not a final determination of non-compliance. A.M. Surgical, Inc. is now responsible for addressing this observation, either by discussing objections or, more commonly, by developing and implementing comprehensive corrective actions. The company must also proactively conduct internal self-audits to ensure full compliance with all applicable regulations.