FDA 483 - Akron Coating & Adhesives Inc - June 27, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 2141747f-6c22-4855-9bcb-0d112cca09bd