# FDA 483 - Univar Solutions USA Inc. - December 11, 2023

Source: https://www.keypedia.com/records/483/univar-solutions-usa-inc/e7d3afe2-bbb5-47bf-9343-d110f2032ac6

> FDA 483 for Univar Solutions USA Inc. on December 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univar Solutions USA Inc.
- Inspection Date: 2023-12-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Univar Solutions USA Inc., a drug repackager and relabeler in Spartanburg, SC, revealed significant deficiencies in its quality system. The firm was cited for a lack of quality unit authority and responsibility in reviewing batch records, incomplete batch production and control records, and failure to follow established laboratory test procedures. These observations indicate a systemic breakdown in cGMP compliance.

## Related Officers

- [Medical Officer at FDA](https://www.keypedia.com/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.keypedia.com/companies/univar-solutions-usa-inc/cd09fe5f-fa22-43e6-927f-f0b3329edce7

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7