FDA 483 - QuVa Pharma, Inc. - August 18, 2022

An FDA Form 483 was issued to a drug product manufacturing facility following an inspection. The facility produces drug products including Cefazolin PF and Methoietheal Sodium 100mg/10 mL PF.

Three observations were noted:

1. **Lack of Employee Training:** On July 27, 2022, an EM Technician and a Compounding Technician were observed failing to follow proper sterile gowning procedures in the ISO 8 Anteroom before entering the ISO 7 Cleanroom. The EM Technician touched the outside of the gown and a cart, while the Compounding Technician failed to adjust shoe covers. The firm's Sterility Assurance Manager intervened. This indicates a deficiency in training for employees performing critical manufacturing and processing functions.

2. **Deficient Finished Product Conformance Determinations:** On July 12, 2022, finished drug products, Methoietheal Sodium 100mg/10 mL PF, Lot Numbers (b) (4) and (b) (4), were found at room temperature in the (b) (4) Laboratory awaiting receipt, despite the product label specifying refrigeration. The Laboratory Supervisor stated samples are not refrigerated until checked into the lab due to limited space.

3. **Failure to Follow Written Stability Testing Program:** A review of the Dexamethasone Phosphate 6mg in 25mL NS (0.24mg/mL