FDA 483 - CEP Bio-Coat, LLC - September 29, 2020

An FDA inspection of CEF Bio-Coat, LLC in Farmington Hills, MI, a medical device establishment, revealed six significant quality system deficiencies. Many of these observations were repeats from previous inspections and a Warning Letter, highlighting persistent issues with the firm's corrective and preventive actions, process validation, and control of nonconforming products. The findings indicate a lack of adequate procedures and implementation across several critical manufacturing and quality control areas.