FDA 483 - Akron Coating & Adhesives Inc - June 27, 2022

An FDA inspection of Akron Coating & Adhesives Inc. in Akron, OH, revealed multiple significant deficiencies in their manufacturing and quality control systems for drug products. Key issues included inadequate stability testing, insufficient laboratory controls, and a lack of proper process validation and equipment calibration. The firm also failed to perform microbiological testing on non-sterile products and exhibited poor adherence to quality control unit procedures, including change control and deviation management.