Queens Express Pharmacy – FDA 483, Jul 11, 2016

During an inspection, the FDA observed five deficiencies at the firm.

**Observation 1:** Aseptic processing areas lacked a sufficient system for monitoring environmental conditions. Viable surface sampling using [(b) (4)] was conducted [(b) (4)] and not consistently on cleanroom operation days. Residual media from sampling could be left on LAF surfaces, requiring cleaning, but no written instructions existed for this.

**Observation 2:** Procedures to prevent microbiological contamination of sterile drug products were not established. Personnel monitoring was limited to fingertip sampling with [(b) (4)]. Drug product vials and diluent bags were transferred, [(b) (4)] with a [(b) (4)], and wiped with sterile [(b) (4)], but no contact time was established for this wiping.

**Observation 3:** Personnel clothing was inappropriate. Gloves available for cleanroom personnel were from a manufacturer previously removed from the approved list due to tearing issues. Management stated they had run out of the replacement gloves.

**Observation 4:** Aseptic processing areas were deficient in maintaining equipment for aseptic conditions. A smoke study video was found to [(b) (4)] and was not conducted under dynamic conditions representative of actual operations, including the maximum number of employees. The LAF in the video contained no other materials, but actual operations showed a technician working closely with the LAF operator [(b) (4)].

**Observation 5:** Drug products were not stored under appropriate