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

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.