# FDA 483 - CGG Medical Inc - February 11, 2019

Source: https://www.keypedia.com/records/483/cgg-medical-inc/9c1c68f7-2131-45af-ba3b-59c53893cb6e

> FDA 483 for CGG Medical Inc on February 11, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CGG Medical Inc
- Inspection Date: 2019-02-11
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Veritas Surgical Solutions, a human tissue distributor in Tallahassee, FL, was cited for significant deficiencies in its quality system. The inspection revealed a widespread lack of established, documented, and followed procedures for critical operations, including HCT/P manufacturing steps, record-keeping, facility sanitation, and complaint handling. These issues indicate a fundamental breakdown in maintaining current good tissue practices.

## Related Documents

- [483 - 2021-07-21](https://www.keypedia.com/records/483/cgg-medical-inc/cc0b6db4-0b1e-4604-af4e-306bc230be3a)

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.keypedia.com/companies/cgg-medical-inc/40a6e751-f818-455e-bd9c-7c1dd3017021

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6