FDA 483 - IntegraDose Compounding Services LLC - August 12, 2026

IntegraDose Compounding Services LLC, located in Shoreview, MN, underwent an FDA inspection from August 4 to August 12, 2026. The resulting report outlines several significant violations regarding aseptic processing and quality control oversight at this outsourcing facility. The primary concerns involve the facility"s failure to maintain sterile conditions. Specifically, the firm continued drug production and distribution despite known HEPA filter failures and active red warning lights on filtration units. Management failed to investigate these malfunctions or assess the potential impact on products already shipped to healthcare providers. Additionally, operators were observed using poor aseptic techniques, such as moving too quickly in cleanrooms and failing to properly disinfect components before use. The inspection also highlighted a lack of effective quality oversight. The firm moved to a new facility but failed to requalify its visual inspectors for the new environment. Batch records were frequently incomplete, missing critical data such as processing times and lighting levels. Furthermore, sterility validation tests, known as media fills, were not reviewed or signed by the Quality Unit until months after they were completed. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. IntegraDose is required to respond to these findings with a detailed corrective action plan. This plan must address the technical failures of the ventilation system, update standard operating procedures to reflect current operations, and ensure that all personnel are adequately trained and qualified to perform sterile compounding tasks.