# FDA 483 - Univar Solutions USA LLC - October 29, 2024

Source: https://www.globalkeysolutions.net/records/483/univar-solutions-usa-llc/75a93bca-842a-4f82-a9ef-65d28f7e4c7d

> FDA 483 for Univar Solutions USA LLC on October 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Univar Solutions USA LLC
- Inspection Date: 2024-10-29
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Univar Solutions USA, a drug repacker and relabeler in Morrisville, PA, was cited for significant deficiencies in laboratory controls, material testing, and quality unit oversight. Observations included failures in raw material identification testing, inadequate storage conditions for drug products, and a lack of qualified personnel to ensure product quality and data integrity. These issues indicate a systemic breakdown in quality assurance processes.

## Related Officers

- [NELSON AYANBADEJO](https://www.globalkeysolutions.net/people/nelson-ayanbadejo/c4bf08fe-7be2-422c-8e83-fd622d105d67)
- [Ruben C. Quintana](https://www.globalkeysolutions.net/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)
- [company_representative](https://www.globalkeysolutions.net/people/nelson-n-ayangho/917cb8ea-904d-41a1-b522-2351d3cb1f74)
- [Elena N. Thomas](https://www.globalkeysolutions.net/people/elena-n-thomas/80a975fe-c475-447e-9471-dedb68a99aae)

Company: https://www.globalkeysolutions.net/companies/univar-solutions-usa-llc/a06c02ee-3214-4c46-a71f-9209bbcad15a

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8