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

During an FDA inspection conducted from October 3 to October 12, 2022, medical device manufacturer CEP Bio-Coat, LLC received a Form FDA 483 detailing significant observations regarding its quality system. The main issues identified pertained to inadequate procedures for corrective and preventive actions (CAPA) and insufficient control over nonconforming products. The first observation cited deficiencies in CAPA, including process validation remediation activities not commensurate with risk, such as continuing sterile packaging operations without adequately validated performance qualifications and an insufficient visual inspection test method. Additionally, the company failed to adequately identify necessary corrective actions, exemplified by not gathering complete customer requirements for critical process parameters. Procedures for assessing risk were also found lacking, as required periodic risk reviews for key processes had not been conducted. The second observation highlighted inadequate procedures for handling nonconforming products. This was illustrated by the firm accepting devices that failed endotoxin testing under concession, without scientific evidence to support conformity or ensuring all affected customers were notified. These observations indicate potential non-compliance with the quality system requirements under the Federal Food, Drug, and Cosmetic Act. CEP Bio-Coat, LLC has committed to correcting the identified deficiencies.