FDA 483 - Applied Medical Coatings, LLC - October 13, 2021

Applied Medical Coatings, LLC, a medical device contract manufacturer in Lockport, NY, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, process controls, corrective and preventive actions, control of nonconforming product, calibration procedures, and personnel training documentation. These issues indicate a lack of adequate quality system procedures and adherence to established requirements.