# FDA 483 - WES Pharma Inc. - November 20, 2025

Source: https://www.keypedia.com/records/483/wes-pharma-inc/568aab3e-00d7-49ce-8294-63f21f1fcc8e

> FDA 483 for WES Pharma Inc. on November 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WES Pharma Inc.
- Inspection Date: 2025-11-20
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: This FDA Form 483 report details significant deficiencies at WES Pharma Inc. in Westminster, MD, a human drug manufacturer. Observations include failures in thoroughly reviewing discrepancies, inadequate quality control unit authority over data integrity, and insufficient laboratory record review. Additionally, issues were noted with equipment maintenance and the scientific justification for cleaning validation specifications.

## Related Documents

- [483 - 2023-11-21](https://www.keypedia.com/records/483/wes-pharma-inc/c51662af-2e9d-4582-a9da-1b6e55d8dde7)

## Related Officers

- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/wes-pharma-inc/26195242-bcfc-4382-817b-4d9d153b962d

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa