# FDA 483 - Fareva Richmond, Inc. - September 18, 2023

Source: https://www.globalkeysolutions.net/records/483/fareva-richmond-inc/a7622145-40d8-4b79-9334-c72e1c3f9057

> FDA 483 for Fareva Richmond, Inc. on September 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fareva Richmond, Inc.
- Inspection Date: 2023-09-18
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Fareva Richmond, Inc. in Henrico, VA, revealed significant deficiencies across multiple areas of its drug manufacturing operations. The firm failed to thoroughly investigate product discrepancies and batch failures, maintain proper facility hygiene, and ensure timely quality unit reviews. Additionally, the inspection found non-compliance with stability testing programs, inadequate employee GMP training, and a failure to follow written procedures for equipment maintenance, indicating a systemic lack of control over critical processes.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

Company: https://www.globalkeysolutions.net/companies/fareva-richmond-inc/43039b3d-2ee9-402c-9d67-fd6de7105c98

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