QuVa Pharma, Inc. – FDA 483, Feb 8, 2016

The FDA Form 483 inspection revealed multiple deficiencies in the facility's operations and quality system. A critical finding was the failure to thoroughly review an Out of Specification (OOS) endotoxin result for Vancomycin, lot #13350, with no root cause determined, although the lot was not distributed.

The facility exhibits a lack of an efficient and robust Corrective and Preventive Action (CAPA) system, evidenced by two sterility OOS investigations and fourteen potency OOS investigations remaining open for over thirty days. These include lots of Morphine, Amiodarone, Epinephrine, Oxycontin, Norepinephrine, Ondansetron, Lidocaine, Calcium Gluconate, and Phenylephrine. None of these OOS lots were distributed.

Furthermore, procedures designed to prevent microbiological contamination of sterile drug products lack adequate validation of the sterilization process. Media fill process simulations are not performed under the most stressful or challenging conditions, despite the firm producing high-volume lots.

Aseptic processing areas are deficient in environmental monitoring, with surface sampling routinely performed at incorrect frequencies and not during production. Cleaning and disinfection procedures for aseptic areas are also inadequate; cleaning records for the ISO 5 area do not document the use of a sporicidal disinfectant as required by SOP.

Finally, procedures for the preparation of master production and control records are not adequately described, specifically lacking time limitations for the closure of investigations, contributing to the backlog of open investigations.