# FDA 483 - Univar Solutions, LLC. - April 12, 2024

Source: https://www.keypedia.com/records/483/univar-solutions-llc/9f5d563a-692a-47b5-9d27-2307ead5e747

> FDA 483 for Univar Solutions, LLC. on April 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univar Solutions, LLC.
- Inspection Date: 2024-04-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Univar Solutions, LLC. in Commerce, CA, a repacker of pharmaceutical products, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including the absence of a defined quality control unit, lack of annual product reviews, and inadequate independent verification of master batch records. Additionally, the firm failed to validate laboratory equipment and maintain proper data integrity controls for automated systems.

## Related Officers

- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/univar-solutions-llc/01ad1b00-54e2-48ad-8df9-c258e3d6bc99

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6