Diabetes Corporation of America – FDA 483, Jun 15, 2017

On June 5-15, 2017, the FDA inspected Diabetes Corporation of America dba DCA Pharmacy, a producer of sterile drugs, located at 233 Bedford Way, Franklin, TN. The inspection revealed five observations.

Observation 1 noted that cleaning pads or wipes used in the ISO 5 area were not sterile, specifically (b)(4) wipes used to clean the LAFH. Observation 2 identified difficult-to-clean, particle-generating, or visibly dirty equipment/surfaces in ISO-classified areas. A lyophilizer in the non-hazardous buffer room (ISO 7), adjacent to LAFH (ISO 5), contained (b)(4) with no procedures for external cleaning/disinfection. Environmental conditions for this room, including airflow and particle counts, were not evaluated during lyophilizer operation.

Observation 3 detailed personnel touching surfaces outside the ISO 5 area with gloved hands and proceeding with aseptic processing without changing or sanitizing gloves. This was observed on June 5, 2017, affecting lots T106/PGE-80/LIDO, RX (b)(5), (b)(7)(C), (b)(6), (b)(7)(C) and Phenylepherine/LIDO, RX (b)(5), (b)(7)(C). Observation 4 stated that drug products were released with strength, purity, or quality below purported levels.