FDA 483 - BayCare Integrated Service Center LLC - March 12, 2026

Between February 17 and March 12, 2026, the FDA conducted an inspection of BayCare Integrated Service Center LLC, a sterile drug outsourcing facility in Temple Terrace, Florida. The inspection identified several critical deficiencies in the facility"s quality management and manufacturing processes, primarily centered on the failure to maintain an environment free of microbial contamination.

Key issues included inadequate environmental monitoring, such as failing to test air quality during active production and using incubation methods that could lead to false-negative results. The facility"s cleaning protocols were also deemed insufficient; the cleaning agents used were not validated to kill bacterial spores, even though spore-forming bacteria were repeatedly found in sterile processing areas. Furthermore, the Quality Unit lacked necessary independence, with the same personnel performing sampling, testing, and final product release. In at least one instance, the firm distributed a drug batch before finishing an investigation into a detected microbial recovery.

Additional violations involved flawed visual inspection procedures for IV bags, which did not account for labels potentially obstructing the view of contaminants, and a failure to maintain essential records like surveillance videos used in investigations or annual quality trend reports. These observations indicate that the facility is not operating in full compliance with the regulatory standards of the Food, Drug, and Cosmetic Act. BayCare Integrated Service Center is required to provide a formal response to the FDA, detailing corrective actions or objections to ensure that their products meet essential safety and purity standards.