FDA 483 - Aetna Felt Corporation - May 13, 2021

An FDA inspection of Aetna Felt Corporation, a human drug packager in Allentown, PA, revealed significant deficiencies in their manufacturing and control procedures. The firm lacked written procedures for production controls, failed to conduct annual product reviews, and did not properly qualify or maintain equipment. Additionally, employees lacked adequate GMP training, and labeling controls were insufficient, indicating a broad failure to adhere to current Good Manufacturing Practices.