FDA EIR - Professional Compounding Centers of America dba PCCA - October 29, 2019

The FDA conducted a "for cause" inspection of Professional Compounding Centers Of America, Inc. (PCCA), a registered drug repacker and labeler located in Houston, TX, from October 22 to 29, 2019. This inspection was initiated by the Center for Drug Evaluation and Research (CDER) under an Opioid Quality Survey assignment, focusing on the company's compliance as a drug repacker and relabeler. The inspection, covering Quality, Facilities and Equipment, Materials, Laboratory Control, and Production systems, resulted in two key observations documented on an FDA-483 form. Firstly, the company failed to fully ensure adherence to requirements for Certificates of Analysis (CoA) for materials. Secondly, PCCA did not routinely analyze incoming lots of glycerin raw material from suppliers for the presence of harmful contaminants such as Diethylene Glycol (DEG) and Ethylene Glycol (EG) before releasing them for use in drug product repackaging. These findings highlight critical gaps in their quality control processes for raw material verification. PCCA's management committed to submitting a written response addressing these issues within 15 working days.