Sterility – just on the Label? FDA Warning Letter after Death Cases

A veterinary drug labeled as sterile, but found to be microbiologically contaminated and associated with serious adverse events, has led to an FDA Warning Letter to Sciarra Aeromed, Inc. Following a multistate investigation, an inspection of the manufacturing site in Carmel, New York, and a review of epidemiological and clinical information, the agency identified violations of the Federal Food, Drug, and Cosmetic Act.

The FDA inspected the facility from February 9 to 25, 2026. According to the agency, laboratory analyses confirmed significant microbial contamination of the product labeled as sterile. Several fungal species were identified, including Purpureocillium lilacinum, Paraisaria heteropoda, and Gongronella lacrispora. The FDA considers the contamination a high risk in view of the product’s intended uses: The product could come into contact with internal tissues or enter the systemic circulation. Potential consequences range from wound infections and tissue damage to sepsis and death. The agency describes the incident as particularly serious.

Among the key deficiencies in contamination control, the FDA cites the absence of sporicidal cleaning agents and inadequate cleaning validation. During manufacturing, Sciarra Aeromed did not conduct adequate environmental monitoring in the ISO 5 area or personnel monitoring. Static and dynamic smoke studies to assess airflow were also lacking. The FDA additionally noted deficiencies in the condition of the facility, personnel protective garments and media fills. According to the agency, the simulations did not cover the filling configuration considered to represent the worst case. As a result, the company had not demonstrated that its process could consistently produce sterile products.

In addition to the contamination, the FDA objected to inadequate labeling. The labeling did not provide sufficient directions for use by laypersons. Moreover, describing the product as a sterile solution was misleading in light of the test results. The company informed the agency that it was not currently manufacturing the product and intended to make corrections before resuming production. However, the FDA could not fully assess the company’s response because supporting evidence was missing, including documentation related to media fills, monitoring, the use of sporicidal agents and smoke studies. Read the full Warning Letter on the FDA’s official website.