Positron emission tomography (PET) drug manufacturer SOFIE drew a warning letter from the FDA for fungal contamination in ISO 5 areas at its facility in Sanford, Florida.
An agency inspection revealed a “persistent, adverse trend of fungal contamination,” as indicated by the firm’s own environmental monitoring. Despite the contamination, the facility carried on drug production without taking sufficient measures to deal with the fungi, the agency said.
The firm’s environmental monitoring trend data noted fungal contamination on operator gloves, air and surface samples, including several species of Penicillium. More than 40 environmental and glove monitoring samples from Sep. 2018 through March 2019 contained Penicillium decumbens, but the firm did not fully evaluate the scope of the contamination or how it got into the ISO 5 areas, the agency said.