FDA 483 - QuVa Pharma, Inc. - February 05, 2016

The FDA Form 483 inspection revealed several 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, which was not distributed. The investigation lacked a determination of the root cause.

Additionally, the facility demonstrated a lack of an efficient and robust Corrective and Preventive Action (CAPA) system, evidenced by 14 open OOS investigations exceeding 30 days. This includes three sterility OOS investigations (Nicardipine lot #13384, Oxycotin lot #12772, Morphine lot #13170) and eleven potency OOS investigations (Lidocaine lots #13514, #13438, #13513; Norepinephrine lot #13484; Oxycotin lots #13466, #13621; Amiodarone lot #13515).

Further observations included: - Procedures designed to prevent microbiological contamination of sterile drug products were not established. Media fill process simulations were not performed under the most stressful or challenging conditions, despite the firm producing larger batch sizes. - Aseptic processing areas were deficient in environmental monitoring. Surface sampling was routinely performed less frequently than documented in SOP #103-06.02, and environmental