# FDA 483 - Univar Solutions USA Inc. - February 21, 2025

Source: https://www.globalkeysolutions.net/records/483/univar-solutions-usa-inc/702f97f4-05d7-4342-bd8d-a5616bfbf791

> FDA 483 for Univar Solutions USA Inc. on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univar Solutions USA Inc.
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Univar Solutions USA in Dallas, Texas, an API manufacturer/repacker, revealed significant deficiencies in its quality unit's oversight of cGMP compliance. The firm failed to adequately review and approve batch records, establish necessary procedures, perform annual product reviews, and ensure proper employee training. Additionally, the inspection found that the firm lacked an effective system for identifying and controlling rejected or expired materials under quarantine.

## Related Documents

- [EIR - 2012-12-20](https://www.globalkeysolutions.net/records/eir/univar-solutions-usa-inc/332fee0d-c3af-4163-8dce-a946cff26625)
- [EIR - 2014-01-08](https://www.globalkeysolutions.net/records/eir/univar-solutions-usa-inc/43d7e65b-c1c4-4af1-a580-87262c239fdc)
- [483 - 2025-02-21](https://www.globalkeysolutions.net/records/483/univar-solutions-usa-inc/bc5c46cc-2980-47a7-97ea-2b244382dffd)

## Related Officers

- [Milton Defesa Taravez](https://www.globalkeysolutions.net/people/milton-defesa-taravez/7feb3e5b-7cd3-4e87-9f51-39be2f7a1539)
- [Medical Officer at FDA](https://www.globalkeysolutions.net/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.globalkeysolutions.net/companies/univar-solutions-usa-inc/5f18ce8e-0ac8-402c-b811-4c9feb72d717

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