COPY-FDA Find Bugs, Bird At Affiliate Of Meningitis Pharmacy
(Reuters) - U.S. health inspectors found bugs, a flying bird and other unsterile conditions atAmeridose LLC, an affiliate of the Massachusetts compounding pharmacy at the heart of the deadlymeningitis outbreak.
Westborough, Massachusetts-based Ameridose was closed on October 10 to allow state and federal investigators to inspect its facilities. On Monday the U.S. Food and Drug Administration released the results of its investigation.
The agency's report details a list of quality control failures at Ameridose, including a failure to test the potency of its products, a failure to properly classify patient complaints and the use of "vague, canned language" when describing negative patient reactions to its drugs.
The company, an affiliate of the New England Compounding Center, said it is in the process of preparing a full response to the FDA.
"Ameridose's history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product," the company said in a statement. "Ameridose is committed to addressing all observations in order to enhance our existing systems." click here to read more