FDA finds contamination issues at Ameridose

WASHINGTON (AP) — Federal health inspectors found more than a dozen manufacturing problems, including leaky ceilings and insects, at a drug-making facility with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.

The Food and Drug Administration on Monday released the results of a month-long inspection of Ameridose, a Westborough, Mass.-based company that makes injectable drugs.

Inspectors said they found insects within ten feet of a supposedly sterile area where drugs were manufactured. In another case, inspectors reported a bird flying into a room where drugs are stored.

Elsewhere, the report cited leaks and cracks in the ceiling and walls of a clean room used to manufacture sterile drugs. The same room contained "thick residues that were orange, brown, and green" on autoclave equipment.

The agency's report, posted online, reported a host of other problems at the company's plant. FDA inspectors said the company did not investigate at least 53 incidents of bacterial contamination that arose during production.

"There is no documented evidence that your firm implemented permanent corrective actions to prevent these sterility events from recurring," investigators wrote.

Ameridose agreed to shut down for inspection in October after tainted steroids from its sister company, the New England Compounding Center, were linked to a fungal meningitis outbreak that has spread to 19 states and caused 32 deaths. The company later agreed to recall all of its products under pressure from FDA regulators. FDA officials previously said they had not connected any Ameridose drugs to infection or illness, but they have concerns about the products' sterility.

The company said it will work to address the issues cited by FDA, but stressed: "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."

Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, has resigned from Ameridose.

Cox Media Group