# FDA 483 - Nesher Pharmaceuticals (USA) LLC - October 20, 2019

Source: https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/55cc577c-2caf-41a9-976a-6899e529683d

> FDA 483 for Nesher Pharmaceuticals (USA) LLC on October 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nesher Pharmaceuticals (USA) LLC
- Inspection Date: 2019-10-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Nesher Pharmaceuticals (USA) LLC in Bridgeton, MO, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adequately validate test methods, thoroughly investigate out-of-specification results and product complaints, and maintain proper controls over computer systems. These issues indicate a lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.

## Related Documents

- [483 - 2019-07-31](https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/9f917538-32c3-450f-a15b-06d2a346184b)
- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/19eb3ba6-8379-4c92-86c9-d561caef488f)

## Related Officers

- [Ana F. Sandee](https://www.globalkeysolutions.net/people/ana-f-sandee/2f5c053f-73d2-43e3-85a3-7565d73a9d29)
- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)
- [William F. Lagud](https://www.globalkeysolutions.net/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)
- [investigator](https://www.globalkeysolutions.net/people/shirshendu-k-deb/d8e51b5d-e39c-46c5-893d-b01261babec4)

Company: https://www.globalkeysolutions.net/companies/nesher-pharmaceuticals-usa-llc/5198bc9c-156b-4adf-ab9d-7ca6271a62bb

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