# FDA 483 - UNIVAR SOLUTIONS USA INC. - August 11, 2023

Source: https://www.keypedia.com/records/483/univar-solutions-usa-inc/c4184724-6e48-4dd0-80ed-deed5b7e121f

> FDA 483 for UNIVAR SOLUTIONS USA INC. on August 11, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: UNIVAR SOLUTIONS USA INC.
- Inspection Date: 2023-08-11
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: UNIVAR SOLUTIONS USA INC. in Cincinnati, an API repackager, received a Form 483 with three observations, including a repeat observation from 2021. The inspection revealed significant deficiencies in quality control oversight, component identification testing, and equipment maintenance practices, particularly concerning the repackaging of Isopropanol 99% USP. These issues indicate a lack of adherence to Current Good Manufacturing Practice.

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Investigator ](https://www.keypedia.com/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)

Company: https://www.keypedia.com/companies/univar-solutions-usa-inc/79b37228-7a54-4baf-a670-8a05f802fbd1

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22