SCIARRA AEROMED, INC – FDA Warning Letter, Feb 25, 2026

On September 23, 2026, the FDA issued a Warning Letter to Sciarra Aeromed, Inc., following inspections conducted from February 9 to February 25, 2026. The investigation was prompted by numerous serious adverse events and animal fatalities linked to the company’s purportedly sterile veterinary products. Laboratory analysis confirmed significant fungal contamination, including species such as Purpureocillium lilacinum, in products labeled as sterile. The FDA identified several critical violations of the Federal Food, Drug, and Cosmetic Act. Products were deemed adulterated due to production under insanitary conditions. Key issues included the failure to use sporicidal cleaning agents, inadequate environmental and personnel monitoring, and the absence of airflow "smoke" studies to ensure sterile conditions. Additionally, the manufacturing facility was in poor repair, with observed ceiling leaks and gaps susceptible to pest entry. The products were also found to be misbranded because they lacked adequate directions for use and contained false claims regarding sterility. Sciarra Aeromed must provide a written response within 15 working days outlining specific corrective actions and providing supporting documentation for media fills, cleaning protocols, and environmental monitoring. The FDA strongly recommends the company hire a qualified consultant to ensure the facility meets industry standards for sterile manufacturing before resuming production. Failure to address these systemic flaws may lead to further legal or regulatory action.