# FDA 483 - Amneal Pharmaceuticals LLC - November 28, 2018

Source: https://www.keypedia.com/records/483/amneal-pharmaceuticals-llc/f232c05f-c8fd-4a53-b862-2dee72ded3f1

> FDA 483 for Amneal Pharmaceuticals LLC on November 28, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals LLC
- Inspection Date: 2018-11-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Amneal Pharmaceuticals LLC, a drug packager in East Hanover, NJ, received two observations during an FDA inspection. The firm was cited for not having adequate written procedures for production and process controls, specifically regarding packaging process performance qualifications. Additionally, the inspection found that equipment and utensils were not cleaned at appropriate intervals, as the cleaning validation study failed to include worst-case dirty conditions.

## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)

Company: https://www.keypedia.com/companies/amneal-pharmaceuticals-llc/dfe28c99-faab-4039-90dc-5d5c55de1095

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961