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

Source: https://www.globalkeysolutions.net/records/483/cep-bio-coat-llc/61b35bb3-ffcf-4387-8b48-876ce3470407

> FDA 483 for CEP Bio-Coat, LLC on October 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CEP Bio-Coat, LLC
- Inspection Date: 2022-10-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Documents

- [483 - 2019-02-15](https://www.globalkeysolutions.net/records/483/cep-bio-coat-llc/b49bd5d2-284f-4946-91cc-ad019bb6608f)
- [483 - 2020-09-29](https://www.globalkeysolutions.net/records/483/cep-bio-coat-llc/831b700a-096a-498e-a735-e21120c27317)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

Company: https://www.globalkeysolutions.net/companies/cep-bio-coat-llc/3f1e2dce-40c6-4608-94a6-1955bfe593b9

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0