FDA 483 - Pharma Nobis LLC - July 01, 2015

An FDA inspection of Humco Holding Group, Inc. in Texarkana, TX, an OTC drug manufacturer, revealed significant deficiencies across multiple areas. The firm lacked adequate written procedures and process validation for drug products, failed to properly qualify its purified water system, and did not thoroughly investigate out-of-specification results or equipment discrepancies. These issues indicate a broad failure to adhere to current Good Manufacturing Practices.