# FDA 483 - Avanti Polar Lipids - July 07, 2023

Source: https://www.keypedia.com/records/483/avanti-polar-lipids/463261f3-8aad-4200-af6b-15f1939ba298

> FDA 483 for Avanti Polar Lipids on July 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avanti Polar Lipids
- Inspection Date: 2023-07-07
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: During an inspection from July 5-7, 2023, Avanti Polar Lipids, an excipient manufacturer in Alabaster, AL, was cited for inadequate controls over computer systems. The firm's data integrity Standard Operating Procedures (SOPs) were found deficient, specifically lacking proper management of chromatography audit trails and user privileges, indicating significant concerns with data reliability.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)
- [Program Coordinator](https://www.keypedia.com/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)

Company: https://www.keypedia.com/companies/avanti-polar-lipids/4a19dfa0-1561-4e19-bc71-434d141cb0a1

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7