FDA 483 - QuVa Pharma, Inc. - October 28, 2024

An FDA Form 483 was issued to QuVa Pharma, Inc. in Sugar Land, TX, following an inspection conducted from September 24, 2024, to October 28, 2024. This document details objectionable conditions observed by FDA investigators, which do not constitute a final determination of compliance.The primary observations indicate significant lapses in procedures designed to prevent microbiological contamination and ensure drug product integrity during distribution. Specifically, the firm failed to adequately investigate incidents related to disinfectant contact time discrepancies within critical aseptic processing areas (ISO 5 BSC/LAFU units). Investigations into "Personnel Error" as a root cause were deemed insufficient, lacking a detailed impact assessment supported by scientific study and data for deviations from established cleaning and disinfection protocols.Furthermore, QuVa Pharma, Inc. exhibited deficiencies in validating its shipping and packaging processes. The firm's pack-out validation reports were found to be limited, assessing only 3 ml syringe packaging for temperature control during shipping. This validation failed to cover larger syringe sizes (e.g., 5 ml, 10 ml, 20 ml, 30 ml, and 50 ml) or larger customer order quantities. Additionally, the firm did not adequately assess packing components and methods to ensure the integrity of all primary packaging types during shipment, even after receiving reports of cracked syringes.These observations highlight concerns under the Federal Food, Drug, and Cosmetic Act, particularly regarding the preparation, packing, or holding of drugs under conditions that could render them injurious to health or contaminated. QuVa Pharma, Inc. is required to address these findings and implement comprehensive corrective actions to ensure compliance with regulatory standards.