# FDA 483 - Nesher Pharmaceuticals (USA) LLC - July 31, 2019

Source: https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/9f917538-32c3-450f-a15b-06d2a346184b

> FDA 483 for Nesher Pharmaceuticals (USA) LLC on July 31, 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: 2019-07-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Wesher Pharmaceuticals (USA) LLC in Bridgeton, MO, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification and out-of-trend stability results for Oseltamivir Phosphate for Oral Suspension, lacked adequate written procedures for production equipment, and did not adhere to its established stability testing program. These issues indicate a lack of robust controls over drug product quality and purity.

## Related Documents

- [483 - 2019-10-20](https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/55cc577c-2caf-41a9-976a-6899e529683d)
- [483 - 2021-08-12](https://www.globalkeysolutions.net/records/483/nesher-pharmaceuticals-usa-llc/19eb3ba6-8379-4c92-86c9-d561caef488f)

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Bei Y. He](https://www.globalkeysolutions.net/people/bei-y-he/6ee057b7-9558-4f4c-b312-9a63821699c2)

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