FDA: Ameridose Is Rife With Contamination Issues

Bugs, leaks found inside drug firm linked to outbreak
By Rob Quinn,  Newser Staff
Posted Nov 13, 2012 5:14 AM CST

(Newser) – The FDA's monthlong inspection of Ameridose, a firm with the same founders as the pharmacy linked to a deadly meningitis outbreak, has produced a long and troubling list of contamination issues, the AP reports. Inside the company's drug-making facility, federal inspectors found leaky, cracked walls and ceilings, insects within 10 feet of an allegedly sterile area where drugs were stored, and "thick residues that were orange, brown, and green" on sterilization equipment. Inspectors also spotted a bird flying around a room where sterile products were packaged.

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Inspectors and regulators also found that Ameridose received dozens of complaints from patients and doctors that various drugs didn't work, and it failed to investigate multiple reports of serious side effects. The FDA's findings are "just stupefying," the head of a pharmacy consulting firm tells the New York Times. "It’s an operation that is totally out of control," he says. "Especially when you look at the patient complaints, that is scary as all get-out." He predicts the firm will never open again, saying it's "unfathomable that they were able to operate for as long as they did." (Read more Ameridose stories.)

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