FDA 483 - QuVa Pharma, Inc. - December 08, 2016

On December 8, 2016, FDA investigators Stephen D. Brown and Lisa R. Jennings issued a Form 483 to QuVa Pharma, Inc., an outsourcing facility located at 5920 S General Bruce Dr Ste 100, Temple, TX 76502-5804. The inspection, conducted from November 28 to December 8, 2016, identified several deficiencies.

**Key Observations:**

1. **Aseptic Processing Area Cleaning and Disinfection:** The firm failed to perform effectiveness testing for disinfectants, such as [(b) (4)] and [(b) (4)], routinely used in ISO 5 [(b) (4)] areas. 2. **Environmental Monitoring:** The firm did not continuously record pressure differentials between ISO 5 [(b) (4)] and ISO 7 Clean Rooms during aseptic drug production. Additionally, pressure gauges measuring the differential from the [(b) (4)] to the [(b) (4)] lacked an alarm system, violating SOP COR-SOP-T0-0002, Version 01, Section 4.2. 3. **Air Supply Filtration:** The "Air Flow Smoke Pattern Test" in the [(b) (4)] Certification Report for each [(b) (4)] lacked documentation to show it was performed under dynamic conditions. 4. **Drug Product Label