QuVa Pharma, Inc announces the arrival of an inspection closeout letter (an Establishment Inspection Report [EIR]) from the FDA concluding its review of the operations in a Temple, Texas facility previously owned by Unique Pharmaceuticals Ltd (UPI). QuVa Pharma acquired the Temple assets of UPI, including its 503B manufacturing facility, on October 30, 2015. The FDA letter states that an EIR is issued when the inspection of the facility is closed. The FDA acknowledged the corrective actions taken in response to the concerns raised by the FDA during previous inspections at the UPI facility. The 503B manufacturing facility recently underwent extensive modification, including installation of closed, restricted access barrier compounding units designed to minimize the risk of product contamination by operators. All products produced at the facility undergo complete USP <71> testing for sterility, as well as additional testing for potency and endotoxins.