FDA Finds Insects, Bird at Ameridose

Ameridose responded to the findings in a statement.

Federal Food and Drug Administration inspectors saw insects and a bird while inspecting Ameridose, a Westborough facility that shares owners with the Framingham company connected to a national meningitis outbreak, WCVB reported today.

The insects were seen "within 10 feet of a supposedly sterile area where drugs are manufactured," WCVB reported. "In another case, inspectors reported a bird flying into a room where drugs are stored."

Ameridose responded to the findings in a statement.

“We have received the FDA’s written observations included in their Form 483 that is based on a comprehensive 30-day review of our facilities and our processes, conducted by more than 20 inspectors representing both state and federal agencies," the statement reads.

"While 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, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”

Ameridose has been temporarily closed since Nov. 2 to enable the inspection.

Last week, the Boston Globe reported that 650 workers would be laid off at Ameridose and 140 at its affiliated marketing company, Medical Sales Management, starting this past Friday and expecting to occur through the end of the month.

Ameridose has not been directly implicated in the meningitis outbreak. Its sister company, the Framingham-based New England Compounding Center, had its license revoked and is blamed for producing steroid injections that caused 31 deaths and 424 cases of fungal meningitis and joint infections. 

Ameridose has voluntarily recalled its drugs.

William Dougstash January 08, 2013 at 04:32 AM
I heard they found many empty cans of Billy Beer in and around the clean room


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