# FDA 483 - Nesher Pharmaceuticals (USA) LLC - August 12, 2021

Source: https://www.keypedia.com/records/483/nesher-pharmaceuticals-usa-llc/19eb3ba6-8379-4c92-86c9-d561caef488f

> FDA 483 for Nesher Pharmaceuticals (USA) LLC on August 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nesher Pharmaceuticals (USA) LLC
- Inspection Date: 2021-08-12
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: Nesher Pharmaceuticals (USA) LLC, a human drug manufacturer in Bridgeton, MO, was inspected by the FDA. The inspection revealed significant issues with the firm's quality control unit, including inadequate procedures for water system microbiological testing and a failure to address recurring contamination. Additionally, the firm's investigation records for critical product defects were found to be incomplete, lacking proper conclusions and follow-up documentation.

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## Related Officers

- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [Investigator](https://www.keypedia.com/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)

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

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79