FDA 483 - KVK Tech, Inc. - March 14, 2025
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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.
ID · 8d1befc6-0bed-4904-beeb-c20702373802