FDA 483 - A.M. Surgical, Inc. - July 27, 2021

An FDA inspection of A.M. Surgical, Inc. in Smithtown, NY, a manufacturer and importer of Class II medical devices, revealed significant deficiencies in its quality system. Observations included inadequate control over contract manufacturers, poorly defined supplier requirements, and insufficient procedures for design changes and product release. The firm also lacked established statistical techniques for process and product characteristic verification.