FDA: Problems found at another facility of sister company of pharmacy tied to meningitis
Injectable steroids distributed by the New England Compounding Center are blamed for a widespread meningitis outbreak.
November 12th, 2012
08:26 PM ET

FDA: Problems found at another facility of sister company of pharmacy tied to meningitis

Federal inspectors found crawling insects, corroding walls and concerns about safety and quality safeguards at a  drug-making facility run by the company tied to a deadly meningitis outbreak, according to a report released today.

The U.S. Food and Drug Administration issued its report after a nearly month-long investigation of a Massachusetts plant run by Ameridose. Tainted injectable steroids from the now-closed New England Compounding Center, a compounding pharmacy that is a sister company of Ameridose and is run by the same management, are blame for 32 deaths out of 428 cases of presumed fungal meningitis and 10 peripheral joint infections in 19 states, the U.S. Centers for Disease Control and Prevention said.

Ameridose issued a statement later Monday playing up its record and saying it is "in the process of preparing a full response for presentation to the FDA."

"While (our) history shows clearly that we have not had any instance of contaminated products over the course of the past six years, ... Ameridose is committed to addressing all observations in order to enhance our existing systems," the company said.

Ameridose's drug-manufacturing facility is licensed and regulated by the FDA.

Since 2007, the company has received more than $800,000 in drug orders from federal agencies, including the Department of Defense and Department of Veteran Affairs, according to federal records. That number was confirmed by the company and by the FDA.

According to Monday's FDA report, Ameridose got about 33 complaints its products were ineffective or caused "patient response events" different than they should have. These included drugs such as Oxycontin, Ephedrine and Fentanyl that "were not tested for potency" before being distributed, the FDA said, but it did not specify where the products were manufactured.

When there were complaints for things like "fetal distress," "post-partum hemorrhaging," "shortness of breath" and an "unresponsive" patient, Ameridose didn't label them "adverse events" and its investigations didn't take into account the patient outcome, according to the FDA.

Besides tests of their potency, inspectors found that Ameridose "does not test final units of finished (products) for sterility and the presence of bacterial endotoxin."

In 53 cases in which "microbiological contamination (was) observed," the company "failed to investigate," the FDA said. Generally, inspectors faulted Ameridose for inadequate safeguards to prevent contamination, citing issues like gowns, gloves and glasses of personnel not being sterile and their foreheads being exposed.

The report - which the FDA said is comprised of "inspectional observations" but does "not represent a final agency determination" - also suggested problems at the facility itself. According to the report, Ameridose didn't do tests "after penetrating leaks were found;" some walls appeared to be "cracked, corroded and covered with what appeared to be adhesive material" in room where sterile drugs were prepared."

Inspectors faulted the facility's cleanliness as well, saying the "facility is not adequately designed and controlled to prevent (an) influx of contamination" and observing at least one bird and insects within 3 to 10 feet of what should have been sterile products.

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Filed under: Health • Massachusetts
soundoff (9 Responses)
  1. Jeff Frank (R-Ohio) "You Can't Fix Stupid"

    Amerrydose? Kinda looks like the FDA must be contaminated itself, the way these companies are standing up to them. Oxycontin, Ephedrine, and what else don't work? Oh yeah Fentanyl. That's a class IV narcotic, isn't it? And all this crap don't work right? What they don't tell you, is that the users are cross contaminated with cannibis, meth amphetamine, Walmart spray paint. But alas and alack, they'll wait for all this legal discovery to run it's course to come back to the FDA and say....I told ya so.

    November 12, 2012 at 10:27 pm | Report abuse |
    • Mickey1313

      First of all jeff, they are class II, bigger numbers are less controlled. Second cannabis doesn't interact with any known scheduled narcotic. But nice to see that your man loosing hasn't weakned your radically right point of view.

      November 13, 2012 at 12:16 pm | Report abuse |
  2. Don W.

    There is no excuse for this in a place trusted to make pharmacuticals! Why are so many people deceased because of such a horrible disease? Someone needs to goto jail, immediately!

    November 13, 2012 at 9:16 am | Report abuse |
    • Mickey1313

      Out has also come out that it has been literally years since their clean room had undergone certification, something that is required every six months.

      November 13, 2012 at 12:19 pm | Report abuse |
  3. chrissy

    Oxycontin kills people. Or at the least cause irreperable harm to them!

    November 13, 2012 at 10:00 am | Report abuse |
  4. chrissy

    @ Mickeyl3l3, sure makes you hesitant on taking prescription meds dont it?

    November 13, 2012 at 5:29 pm | Report abuse |
  5. Hollywood

    Why does the FDA wait until there is a major problem before they really do something?

    November 14, 2012 at 8:46 am | Report abuse |
  6. chrissy

    Since there is no one over seeing what they do or in this case, dont do, sloppy work ethics are now Standard Opperating Procedure! There needs to be a complete overhaul on what is expected work ethics for these gov divisions!

    November 14, 2012 at 7:28 pm | Report abuse |
  7. Scottish Mama

    Okay everyone just grow your own and lit one up. It now seems safer and you know what your getting.

    November 14, 2012 at 7:35 pm | Report abuse |