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

Source: https://www.keypedia.com/records/483/univar-solutions-llc/21fe4b45-7b99-4f23-b349-2f76dca83ca3

> 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: Los Angeles District Office
- Summary: During an FDA inspection from April 8-12, 2024, Univar Solutions, LLC., a repacker located in Commerce, CA, received a Form FDA 483 detailing significant observations. The primary issues highlighted failures in the firm's quality management system, indicating non-compliance with essential Good Manufacturing Practices. Specifically, the inspection revealed the absence of a defined and functional quality control unit, with critical responsibilities for batch release not adequately established or followed. The company also lacked procedures for conducting annual product reviews to assess risks and trends for repackaged products like Glycerin USP. Production records showed deficiencies, as master batch records were not independently checked and signed by a second person to ensure data integrity. Furthermore, significant concerns were raised regarding facility and equipment, including the failure to validate laboratory equipment, such as Gas Chromatography and Fourier Transform Infrared Spectroscopy, intended for detecting impurities. Issues with data integrity were also noted, such as an inability to access audit trails and the use of shared administrative passwords for lab computers. Univar Solutions is expected to implement comprehensive corrective actions to address these systemic deficiencies and ensure full compliance with regulatory standards.

## Related Documents

- [483 - 2024-04-12](https://www.keypedia.com/records/483/univar-solutions-llc/9f5d563a-692a-47b5-9d27-2307ead5e747)

## 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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b