# FDA 483 - Cytovance Biologics Inc. - September 19, 2026

Source: https://www.keypedia.com/records/483/cytovance-biologics-inc/f6df097a-5a8e-45c3-9153-af6bc24280ac

> FDA 483 for Cytovance Biologics Inc. on September 19, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cytovance Biologics Inc.
- Inspection Date: 2026-09-19
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Cytovance Biologics Inc., an API manufacturer in Oklahoma City, received a Form 483 citing three observations. The firm failed to conduct adequate investigations into discrepancies, did not fully qualify equipment used in manufacturing, and production personnel were not practicing good sanitation and health habits. These issues indicate deficiencies in quality control and facility maintenance.

## Related Officers

- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9