Nesher Pharmaceuticals (USA) LLCAugust 12, 2021

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

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Record Details

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.

Company: Nesher Pharmaceuticals (USA) LLC
Inspection Date: August 12, 2021
Product Type: Drugs
Office: Kansas City District Office
People: Alan M. Barker (Investigator)
Robert J. Ham (Investigator?)

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ID · 19eb3ba6-8379-4c92-86c9-d561caef488f