Kingchem Laboratories Inc.October 18, 2021

FDA 483 - Kingchem Laboratories Inc. - October 18, 2021

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Kingchem Laboratories Inc., an API manufacturer in Saint Francis, WI, was cited for failing to follow its own written procedures for document control. Specifically, a cleaning log page was found in a laboratory notebook that was not issued by Quality Assurance, contrary to the firm's established good documentation practices. This indicates a breakdown in quality system adherence regarding document issuance.

Company: Kingchem Laboratories Inc.
Inspection Date: October 18, 2021
Product Type: Drugs
Office: Minneapolis District Office
People: Charles L. Zhou (Investigator)
Lori B. Wikstrom
Gregory R. Brinsley

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ID · c8a9554e-e3e8-48d7-a564-f8d4c2e4b803