Regenesis Pharmaceutical Inc. – FDA 483, Jun 18, 2019

An FDA inspection of Regenesis Pharmaceutical Inc. in Santa Ana, CA, a manufacturer and labeler of Pain Killer Natural Ointment, revealed numerous significant cGMP violations. The firm lacked fundamental written procedures and documentation across its quality control unit, employee training, complaint handling, material and finished product testing, batch recordkeeping, process validation, stability testing, reserve sample retention, equipment maintenance, calibration, and labeling controls. These deficiencies indicate a severe lack of adherence to good manufacturing practices.