FDA 483 - Tailstorm Health INC - October 10, 2024

An FDA inspection of Tailstorm Health INC, an outsourcing facility, conducted from September 24 to October 10, 2024, identified significant deficiencies impacting drug product quality and patient safety. The inspection revealed a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification results, including the release of sterile Bevacizumab lots despite positive microbial growth during personnel monitoring and unexplained particulate matter. The firm's Quality Unit also failed to determine root causes or implement adequate corrective actions for multiple personnel monitoring microbial excursions.

Key issues included inadequate validation of aseptic processes, specifically a media fill for Bevacizumab that did not accurately simulate production, and the introduction of sterilized components into ISO-5 environments without proper disinfection. Aseptic processing areas exhibited deficiencies in maintaining controlled conditions, with inadequate smoke studies failing to demonstrate proper airflow, and insufficient environmental and personnel monitoring practices. Furthermore, the company lacked established written procedures for sporicidal cleaning of aseptic filling equipment, despite recovering spore-forming microorganisms. Lastly, certain drug product labels, such as Semaglutide, did not include the "Office Use Only" statement as required by Section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act. Tailstorm Health INC is required to address these observations comprehensively to ensure compliance and product integrity.