FDA 483 - SCA Pharmaceuticals, LLC - March 13, 2026

Between February 17 and March 13, 2026, the FDA conducted an inspection of SCA Pharmaceuticals, LLC, an outsourcing facility located in Windsor, Connecticut. This inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified several critical safety and quality control violations. Primarily, the facility failed to establish and follow procedures to prevent microbiological contamination. Investigators identified 46 reports of microorganisms—including various bacteria and fungi—within ISO-5 sterile zones. Despite these findings, most affected drug batches, including Fentanyl Citrate and Hydromorphone, were released for distribution. Additional observations highlighted poor aseptic techniques, such as employees making fast movements and kicking floor equipment, which risks aerosolizing particles. The FDA also noted that SCA Pharmaceuticals failed to thoroughly investigate over 110 instances of particulate contamination found in drug products since December 2024. Furthermore, the facility’s cleaning protocols were deemed inadequate because disinfectant efficacy studies did not test against all identified organisms and failed to adhere to the manufacturer"s required contact times for killing spores. To address these observations, the firm is required to submit a detailed response to the FDA outlining their corrective and preventive actions to ensure manufacturing processes meet safety standards.