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

The FDA Form 483 details observations from an inspection of a pharmacy producing drug products, including those purporting to be sterile.

Key violations include: 1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established and followed. Pharmacy technicians exhibit poor aseptic techniques, and media fill and gowning test procedures are inadequate. 2. **Product Testing and Release:** Drug products are released without appropriate laboratory determination of conformance to final specifications, identity, and strength of active ingredients. Sixteen products containing preservatives are not tested for preservative content. Additionally, several products with potency failures outside the acceptance range were approved and shipped, including Promethazine (113%), Hydrogen Peroxide (0.3%), Lansoprazole (83%), Hydrochloric Acid (44.8%), Polymyx/Bacitracin/Nystatin (65%), and B Complex 100 (70%). 3. **Investigation of Production Errors:** Production errors and non-conformances are not always adequately investigated and documented. 4. **Personnel Clothing:** Personnel engaged in sterile drug product processing do not wear appropriate clothing, specifically lacking sterile mouth and face covers in aseptic processing areas. 5. **Environmental Monitoring:** Aseptic processing areas lack adequate systems for monitoring environmental conditions, including personnel bio-burden, environmental bio-burden, and cascading air pressure differentials. 6. **Facility Design:** Clean rooms are