# FDA 483 - ALI Pharmaceutical Manufacturing LLC - December 01, 2017

Source: https://www.keypedia.com/records/483/ali-pharmaceutical-manufacturing-llc/2cd46e70-9b2a-475f-92d5-516cc6921f0a

> FDA 483 for ALI Pharmaceutical Manufacturing LLC on December 01, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ALI Pharmaceutical Manufacturing LLC
- Inspection Date: 2017-12-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of American Laboratories Inc. in Omaha, NE, revealed significant deficiencies in their active pharmaceutical ingredient operations. Observations included discarding analytical data to mask process variation, inadequate procedures for handling returned opened products, and inaccuracies in complaint investigations. The inspection also noted issues with the firm's deviation and discrepancy investigation process, potentially leading to undocumented deviations.

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## Related Officers

- [investigator](https://www.keypedia.com/people/diana-k-krepel/6dfec9cd-a933-4d1e-947c-cebb5891796c)
- [Program Expert ](https://www.keypedia.com/people/michele-l-obert/7ac8155e-cc5a-4e89-a885-c68ce69adb4e)

Company: https://www.keypedia.com/companies/ali-pharmaceutical-manufacturing-llc/d3d0fcce-e7cb-4f71-8042-2726fd64e8a8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8