QuVa Pharma, Inc. – FDA 483, Apr 23, 2019

This FDA Form 483 details observations from an inspection of QuVa Pharma. The facility failed to adequately control air pressure, humidity, and temperature, specifically with their (b)(4) system failing to electronically measure, record, and transfer environmental data for Cleanrooms I-(b)(4) on multiple dates in March 2019. During these periods, sterile drug products were aseptically processed without the facility management or quality unit being aware of the data loss, and the (b)(4) system failed to send notifications.

Procedures to prevent microbiological contamination were not followed. On April 5, 2019, processing supplies and drug components blocked first pass air in LAF Hood (b)(4) during aseptic processing of Heparin, potentially causing cross-contamination. On April 8, 2019, an environmental sampling technician failed to re-sanitize gloves after tasks in the ISO 7 area before placing an air sampling unit in a BSC where Cefazolin PF was being processed.

Equipment and utensils were not adequately cleaned and sanitized. Stools in all ISO 7 Cleanrooms, used by compounding technicians, were covered with a material that cannot be adequately disinfected. On April 5, 2019, white and black residue was observed on the HEPA grate in LAF hood (b)(4) during aseptic processing of Morphine PF, with no laboratory analysis performed on the foreign material.

Investigations into