FDA 483 - QuVa Pharma, Inc. - April 02, 2014

The FDA Form 483 details numerous deficiencies at a compounding pharmacy producing sterile injectable human drugs.

**Facility and Operations:** The pharmacy processes over 116 different sterile injectable drug formulations.

**Violations and Observations:** * **Aseptic Technique & Procedures:** Pharmacy technicians exhibited poor aseptic technique, including reaching over open vials, placing non-sterile crates on workbenches, and using a hand-held phone in the aseptic area. Procedures for media fills and gowning were inadequate or non-existent. * **Sterilization & Equipment Qualification:** No media fills had been performed for any of the 116+ sterile formulations. Autoclaves and dry-heat ovens lacked equipment qualification to demonstrate microbial/endotoxin log reduction, relying only on run verification. Materials were hand-carried through the cleanroom without further aseptic protection. * **Product Testing & Release:** 16 products containing preservatives were not tested for preservative content. Several products were released with potency failures outside acceptance ranges (e.g., Promethazine 113%, Hydrocortisone Acid Zinc 48%). * **Investigation of Production Errors:** Investigations into non-conformances, such as dark specks in Morphine, lacked adequate documentation and characterization (e.g., no microscopic examination). * **Personnel Gowning:** Technicians did not wear sterile mouth or face covers, exposing skin to open drug product containers. No written procedure required