FDA 483 - PD-Rx Pharmaceuticals, Inc. - November 10, 2022

PD-Rx Pharmaceuticals, Inc. in Oklahoma City, OK, a drug re-packager, was cited for significant deficiencies in its quality control unit, documentation practices, and employee training. The inspection revealed a lack of proper review and approval for qualification testing, inadequate batch record review, and unapproved changes to written procedures. Additionally, the firm failed to establish adequate production and process control procedures and did not follow proper equipment cleaning protocols.