# FDA 483 - Eagle Analytical Services, Inc. - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/eagle-analytical-services-inc/ee6a1297-69b2-475d-8168-5249217ed1fd

> FDA 483 for Eagle Analytical Services, Inc. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eagle Analytical Services, Inc.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Eagle Analytical Services, Inc. in Houston, TX, a contract testing laboratory, received a Form 483 citing significant deficiencies in its quality control and aseptic processing operations. The inspection revealed failures in conducting dynamic airflow visualization studies, inadequate investigation of non-conformances and deviations, and poor document control practices. These observations highlight a lack of robust quality oversight and adherence to established procedures for ensuring product sterility and data integrity.

## Related Documents

- [483 - 2013-06-17](https://www.globalkeysolutions.net/records/483/eagle-analytical-services-inc/3b2795b8-aa2b-4ba9-b2c2-90c5aa053912)
- [483_RESPONSE - 2013-06-17](https://www.globalkeysolutions.net/records/483_response/eagle-analytical-services-inc/4dc3bd1f-1848-4c9a-963d-f5b352148925)
- [483 - 2019-12-17](https://www.globalkeysolutions.net/records/483/eagle-analytical-services-inc/f0cae3c3-db2b-465e-9fb1-6192cf744807)

## Related Officers

- [Milton J. De Jesus Tavarez](https://www.globalkeysolutions.net/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)
- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.globalkeysolutions.net/companies/eagle-analytical-services-inc/71dcd7b7-dc89-4b02-8f2a-1c80300abf01

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