FDA 483 - KVK Tech, Inc. - March 14, 2025

KVK Tech, Inc. in Newtown, PA, a human drug manufacturer, was cited for significant deficiencies during an FDA inspection from March 3-14, 2025. The inspection revealed repeat observations regarding inadequate cleaning and maintenance of drug manufacturing equipment, including widespread API cross-contamination in "cleaned" areas and equipment. Additional issues included poorly designed equipment for cleaning, unvalidated test methods for cleaning verification, and discrepancies between master batch records and process validation studies.