# FDA 483 - Cytovance Biologics Inc. - June 08, 2026

Source: https://www.keypedia.com/records/483/cytovance-biologics-inc/7c829e5f-6b20-41d1-8204-1ec5de895194

> FDA 483 for Cytovance Biologics Inc. on June 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cytovance Biologics Inc.
- Inspection Date: 2026-06-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Cytovance Biologics Inc. in Oklahoma City, OK, an API manufacturer, revealed significant deficiencies across multiple systems. The firm was cited for repeat observations concerning facility maintenance and equipment qualification, alongside failures in cleaning validation, deviation investigations, raw material testing justification, and labeling procedures. These issues indicate a lack of adequate control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2018-09-19](https://www.keypedia.com/records/483/cytovance-biologics-inc/f6df097a-5a8e-45c3-9153-af6bc24280ac)

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)
- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/cytovance-biologics-inc/a03c370a-5e60-4617-95b1-521a1d305ac2

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab