FDA 483 - ACRX Specialty Pharmacy Inc - July 23, 2021

This FDA Form 483 details observations from an inspection of ACRX Specialty Pharmacy Inc., a producer of sterile and non-sterile drug products, located at 3200 Soaring Gulls Dr Ste 101, Las Vegas, NV 89129-2198. The inspection occurred from July 12, 2021, to July 23, 2021. The report was issued to Eghomware J. Igbinovia, Owner and Pharmacist-in-Charge.

Seven observations were noted: 1. **ISO 5 Aseptic Processing Area Cleanliness:** The ISO 5 classified aseptic processing areas contained difficult-to-clean and visibly dirty equipment/surfaces, which were not cleaned before and after producing Glutathione (BUD MDV) 200 mg/ml Inject Soln, Lot #07122021@8. Specific issues included brownish stains on the HEPA filter cover and frames, a difficult-to-clean gap in a stainless-steel bar pot rack, and unknown stains under light bulbs. 2. **Non-Microbial Contamination:** Dusty, filth-like material was present on a non-sterile hood used for non-sterile and sterile product ingredients. Unknown powders were found on the working surface after cleaning, and unknown stains were on the interior of a hood's front window. Rust-