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

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.