FDA 483 - QuVa Pharma, Inc. - May 04, 2026

During an inspection from April 20 to May 4, 2026, the FDA identified several safety and quality control concerns at QuVa Pharma, Inc., an outsourcing facility located in Sugar Land, Texas. The inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic (FD&C) Act to evaluate the facility"s compliance with sterile drug manufacturing standards. The primary violations involved inadequate procedures to prevent microbiological contamination. Specifically, investigators observed the use of un-sanitized tools to retrieve items from the floor, visible black residue in sterile cleanrooms, and insufficient airflow studies to verify that the environment remains sterile during production. Furthermore, the company failed to properly investigate a equipment failure involving a degrading HEPA filter sealant, which posed a risk of releasing particulates into the sterile air. The firm did not determine if other cleanroom units or previously distributed products were impacted by this issue. Additionally, the physical facility showed signs of poor maintenance, including peeling paint in controlled areas. While this document represents preliminary findings and not a final determination of non-compliance, the facility is expected to address these observations. The general manager has committed to conducting new airflow studies, and the company is encouraged to submit a formal response detailing their corrective actions to the FDA.