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

Source: https://www.globalkeysolutions.net/records/483/cep-bio-coat-llc/831b700a-096a-498e-a735-e21120c27317

> FDA 483 for CEP Bio-Coat, LLC on September 29, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CEP Bio-Coat, LLC
- Inspection Date: 2020-09-29
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

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## 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