FDA 483 - QuVa Pharma, Inc. - June 02, 2017

During an FDA inspection on May 23, 2017, at an unnamed facility, an observation was made regarding the manufacturing of sterile drug products. The observation noted that procedures designed to prevent microbiological contamination were not followed. Specifically, three out of an unspecified number of production technicians were observed resting their elbows on the front areas of multiple laminar airflow hoods while producing sterile drug products.

This behavior occurred during the production of three specific drug products: 1. Ropivacaine HCL PF 0.2%, 2mg/mL, Lot #10003990. NS 200 mL in 250 mL, Cassette (400 mg). This was produced by technician one in clean room (b)(4) inside laminar airflow hood #3, serial (b)(4). 2. Fentanyl Citrate, PF 2mcg/mL/ Bupivacaine HCL PF 0.125% in 0.9% Sodium Chloride, 250 mL, Lot #10003982. This was produced by technician two in clean room (b)(4) inside laminar airflow hood #3, serial (b)(4). 3. Magnesium Sulfate PF 2g added to 5% Dextrose, 50 mL, Lot #10004086. This was produced by technician three in