CEP Bio-Coat, LLCOctober 12, 2022

FDA 483 - CEP Bio-Coat, LLC - October 12, 2022

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Record Details

CEP Bio-Coat, LLC, a medical device firm in Farmington Hills, MI, received a Form 483 for significant quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, including issues with process validation remediation, design transfer, and risk management. Additionally, the firm failed to adequately control nonconforming products, specifically regarding endotoxin test failures and customer awareness of concessions.

Company: CEP Bio-Coat, LLC
Inspection Date: October 12, 2022
Product Type: Device
Office: Division of Pharmaceutical Quality Operations III
Person: Thomas A. Peter (Medical Device Senior Operations Officer at FDA)

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ID · 61b35bb3-ffcf-4387-8b48-876ce3470407