# FDA 483 - Revivicor Inc - January 13, 2023

Source: https://www.keypedia.com/records/483/revivicor-inc/d0728049-c3a2-4358-ad15-9477919353dd

> FDA 483 for Revivicor Inc on January 13, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Revivicor Inc
- Inspection Date: 2023-01-13
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Revivicor Inc. in Blacksburg, VA, was inspected from January 11-13, 2023, and received a Form 483 citing significant deficiencies in its quality control unit. The firm lacked written procedures for critical operations such as investigations, training, and document control, and was found to have uncontrolled documents readily accessible to employees. These issues indicate a fundamental breakdown in the firm's quality system management.

## Related Officers

- [Rose L. Jean-Mary](https://www.keypedia.com/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Alexis M Wormington](https://www.keypedia.com/people/alexis-m-wormington/3de50d21-6e5e-4c29-a927-06728101bf3f)
- [Bachan Y Howard](https://www.keypedia.com/people/bachan-y-howard/b0aafbd9-d53c-4b26-b74e-0ff2a939e2ef)
- [Evgenij A Evdokimov](https://www.keypedia.com/people/evgenij-a-evdokimov/b2731508-357c-4f54-bf7d-d277fb0c0ccf)
- [Raphael O Oyesile](https://www.keypedia.com/people/raphael-o-oyesile/d7abb645-2848-4c9a-9a05-dd821152e8d2)

Company: https://www.keypedia.com/companies/revivicor-inc/68914d5c-e949-404e-8f3b-59ee5b05ebb3

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64