# FDA 483 - Univar Solutions USA InC - November 01, 2021

Source: https://www.globalkeysolutions.net/records/483/univar-solutions-usa-inc/93fdc9a3-6db4-4510-8da6-2b591c967ea7

> FDA 483 for Univar Solutions USA InC on November 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univar Solutions USA InC
- Inspection Date: 2021-11-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Univar USA Inc. in Kent, WA, a repacker/packer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in batch production and control records, including incomplete documentation and missing signatures/dates. Additionally, the firm failed to consistently follow its written production and process control procedures, specifically regarding yield calculation documentation for repacking operations.

## Related Officers

- [Nathaniel B. Phillips-Sylvain](https://www.globalkeysolutions.net/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)

Company: https://www.globalkeysolutions.net/companies/univar-solutions-usa-inc/3be69fe9-75bf-4f0d-af04-fe305d0762bd

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822