# FDA 483 - CEP Bio-Coat, LLC - February 15, 2019

Source: https://www.globalkeysolutions.net/records/483/cep-bio-coat-llc/b49bd5d2-284f-4946-91cc-ad019bb6608f

> FDA 483 for CEP Bio-Coat, LLC on February 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CEP Bio-Coat, LLC
- Inspection Date: 2019-02-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Orchid Orthopedic Solutions, LLC in Farmington Hills, MI, received a Form FDA 483 with seven observations, including repeat findings. The inspection revealed significant deficiencies in quality system procedures, particularly concerning nonconforming product control, CAPA implementation, process monitoring and validation, sampling plans, complaint handling, and quality audit practices. These issues indicate a systemic lack of robust quality management for medical device manufacturing.

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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