FDA 483 - Rpk Pharmaceuticals Inc - February 25, 2019

RPK Pharmaceuticals Inc. dba Pharmedix in Union City, CA, a repacker/relabeler, was inspected from February 25-28, 2019. The inspection revealed significant deficiencies related to employee training and adherence to sanitation procedures, specifically the use of expired hand sanitizer. These issues indicate a lack of control over personnel qualifications and environmental conditions that could impact drug product quality.