FDA 483 - Kalchem International, Inc. - February 21, 2020

Kalchem International, Inc., an API repackager/relabeler and OTC drug manufacturer in Lindsay, OK, was cited for significant deficiencies in its quality control, material handling, production, and laboratory systems. Observations included failures in following QC procedures, inadequate written procedures for material receipt and labeling verification, lack of batch records for re-labeling activities, and insufficient stability data for drug product expiration dates. These issues indicate a systemic breakdown in ensuring product quality and compliance.