FDA 483 - QuVa Pharma, Inc. - March 14, 2019

An FDA inspection of QuVaPharma, Inc., an outsourcing facility in Temple, TX, conducted from February 26 to March 14, 2019, identified significant deficiencies in its manufacturing operations and labeling practices. The observations primarily highlight concerns regarding the firm's compliance with appropriate controls for drug compounding and specific requirements for outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act. Key issues included a lack of written procedures for component handling and the use of non-pharmaceutical grade materials. The inspection revealed inadequate validation of depyrogenation processes, evidenced by a confirmed endotoxin failure, and deficiencies in environmental monitoring within aseptic processing areas, including insufficient surface sampling and unvalidated incubation conditions for monitoring plates. Poor sanitation habits, such as the absence of handwashing facilities and rust/residue on equipment, raised contamination concerns. Furthermore, QuVaPharma was observed compounding drugs that were essentially copies of approved drugs, contradicting Section 503B. Critical information, such as "This is a compounded drug," dosage form, and adverse event reporting instructions, was missing from drug product labels and containers, violating specific labeling requirements. The firm is expected to implement comprehensive corrective actions to address these observations and ensure regulatory compliance.