QuVa Pharma, Inc. – FDA 483, May 31, 2019

The FDA Form 483 inspection revealed multiple deficiencies in the facility's quality control, aseptic processing, environmental monitoring, and laboratory controls.

**Quality Control Unit Deficiencies:** * The quality control unit lacks responsibility for approving and rejecting procedures or specifications impacting drug product identity, strength, quality, and purity.

**Aseptic Process Simulation Issues:** * Missing 60 mL syringe units from aseptic process simulations on 09/20/2018 (Lot #092018LR) and 09/19/2018 (Lot #091918KS) were not incubated or tested for microbial growth. * Syringes used for equipment priming and calibration during these simulations were also not incubated or tested. No explanation was documented for these omissions. * Procedures to prevent microbiological contamination lacked validation of the aseptic process.

**Complaint Handling Deficiencies:** * Investigation records for drug complaints lacked findings and follow-up. * Complaint 0115 (02/04/2019) regarding particulates in Sodium Bicarbonate syringes (e.g., Lot #30001883) determined crystallization in transit, but the investigation did not include stability/formulation review, retain sample review, or particulate identification. * Shipping studies to assess transit conditions' effects on compounded drug products have not been performed