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Contamination Found at Ameridose

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Contamination Found at Ameridose

November 22, 2012 by Parrish Law Firm, PLLC

The Food and Drug Administration has found various potential sources of contamination at a drug-making facility that was founded by the same company as the pharmacy that has been linked to the meningitis outbreak, reports WLFI.com.

Ameridose, a Massachusetts-based company that manufactures injectable drugs, has been undergoing a month-long inspection of its facilities. Inspectors say they found numerous contamination issues ranging from manufacturing to sterility to quality control.

Leaky ceilings, insects, and even birds were found within the facility in an area where drugs were manufactured. Leaks and cracks in the ceiling were found in a room that had “orange, brown, and green” residue on the sterilization equipment. FDA inspectors also claimed that there were at least 53 incidents of bacterial contamination during testing of drug stock solution that remained overlooked.

Ameridose shut down in October for inspection after a meningitis outbreak from its sister company caused 32 deaths. The company also agreed to recall all of its products, though no Ameridose drugs have been linked to infection. On Monday, the company stated that it would address the issues brought up by the FDA and emphasizes its clean record over the past six years.

Source:

  • http://www.wlfi.com/dpp/on_the_money/recalls/FDA-finds-contamination-issues-at-Ameridose_77973681

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