Compounder Receives FDA Warning Letter

FDA sent a warning letter, dated August 25, 2020, to Customceutical Compounding after an investigation of the company’s Phoenix, AZ facility found “serious deficiencies” in its production of sterile drug products. The inspection was conducted from February 27 –March 8, 2019.

FDA investigators found that drug products “were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing drug products to be adulterated under section 501(a)(2)(A) of the FDCA [Federal Food, Drug, and Cosmetic Act], according to the letter. In one case, investigators observed that a technician failed to sanitize materials before placing them into an ISO 5 classified area. Inspectors also noted that personnel were seen in the ISO 5 area with exposed facial skin. Additional violations included using non-sterile cleaning wipes inside the ISO 5 area, failing to adequately sanitize equipment held in the laminar flow hood, and improper gowning.

The warning letter also noted that the company had failed to evaluate or take remedial action during post-aseptic processing glove fingertip testing, when microbial contamination was found on a technician’s glove. Among other deficiencies noted in the letter, the compounder had failed to perform adequate smoke studies to assure unidirectional airflow within the ISO 5 classified area and had failed to provide adequate containment and cleaning of surfaces and equipment.