FDA Finds Violations at Hospital Drug Supplier

The Food and Drug Administration urged a hospital drug supplier to recall all of its products after officials discovered a host of violations—from a leaking ceiling in a "clean room," to a bird flapping around a sterile drug packaging room. The federal agency inspected Ameridose LLC—the sister company of the New England Compounding Center, where the country's deadly meningitis outbreak originated— between Oct. 10 and Nov. 9. The inspection followed reports of pregnant patients hemorrhaging after receiving labor-inducing oxytocin and complaints about the painkiller fentanyl. No infections have been tied to Ameridose products, but the FDA's report noted two potentially harmful violations: the firm's failure to test finished drugs for sterility and for bacteria, and failure to confirm the potency of the final product. In a statement, Ameridose said the company has "not had any instance of contaminated products over the course of the past six years," and that it is "committed to addressing all observations in order to enhance our existing systems."

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