More Compounding Issues From Ameridose, Notes Waxahachie Personal Injury Attorney
Waxahachie, TX (Law Firm Newswire) December 6, 2012 - Disturbing safety issues, including insects and corrosion were found at a drug plant.
Federal inspectors looking for safety and quality issues at a drug-manufacturing facility run by a company currently being investigated for a deadly outbreak of meningitis found numerous issues, including insects and corrosion.
"Individuals depend on drug manufacturers and compounders to observe all precautions and quality measures to ensure the safety and health of the end users is not threatened," stated John Hale, Waxahachie personal injury attorney.
The U.S. Food and Drug Administration (FDA) released a report about the Massachusetts-based plant run by Ameridose, which has stated that it is working on a response to the FDA.
Steroids tainted with a fungus are the cause of at least 32 deaths and almost 430 cases of fungal meningitis. The injectable steroids were made at New England Compounding Center, a compounding pharmacy, now closed, run by Ameridose. Additional plants managed by Ameridose are being investigated.
Ameridose has received in excess of $800,000 in drug orders from various federal agencies since 2007, including some for the Department of Defense and Department of Veteran Affairs. The FDA licenses and regulates Ameridose's drug-manufacturing facility.
The report by the FDA included 33 complaints about Ameridose products that caused a response different from the stated purpose or were blatantly ineffective. The drugs, including Ephedrine, Fentanyl and Oxycontin were not tested for their potency prior to public distribution. The complaints included issues of fetal distress, post-partum hemorrhaging, and shortness of breath, but Ameridose reportedly did not follow up.
In addition to not testing for potency, the FDA inspectors report that Ameridose typically did not appear to test final units of drugs for either sterility or the presence of contaminants. In more than 50 cases where there was observable drug contamination, Ameridose did not investigate it, stated the report. Also, investigators found birds and insects within just a few feet of products that are supposed to stay sterile, and found inadequate contamination safeguards, including no sterile gowns, gloves and glasses.
The FDA report was comprised of "inspectional observations" and is not a final determination by the agency.
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Waxahachie, TX 75165
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