FDA 483 - KVK Tech, Inc. - April 16, 2019

An FDA inspection of KVK Tech, Inc. in Newtown, PA, a drug product manufacturer, from April 9-16, 2019, revealed significant deficiencies across multiple quality systems. The firm failed to establish adequate written procedures for its quality control unit, thoroughly investigate product discrepancies and batch failures, and maintain proper laboratory controls and data integrity. These observations indicate a lack of adherence to Good Manufacturing Practices, raising concerns about product quality and reliability.