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4 Bumps

Why is the FDA so slack? Check your med cabinets mom's!

FDA knew of problems at plant that made tainted alcohol wipes;
Documents show sterilization issues as early as 2009; dozens may have been sickened.

The death of a 2-year-old Houston boy from a rare infection blamed on contaminated alcohol wipes may be only the first casualty tied to allegedly shoddy sterilization practices by a Wisconsin medical products firm.

Since reported Feb. 15 about the death of Harrison Kothari , who was infected with the same type of rare bacteria that sparked the recall of tens of millions of pads and swabs, dozens of people have stepped forward to say they may have been sickened, too.

At the same time, government documents obtained by showed that federal Food and Drug Administration inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group of Hartland, Wis., as early as July 2009.

“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” officials wrote in inspection reports. But there's no record that the FDA sent warning letters typically used to force firms to comply.

Due to improper sterilization, there have been skin infections, serious complications requiring surgery, abnormal pap smear results tied to the lubricating jelly, and death.


Asked by Anonymous at 4:04 PM on Feb. 22, 2011 in Politics & Current Events

This question is closed.
Answers (7)
  • The Quality control people at these factories/production plants needs to step up their game too. It seems like every time you turn around something is being recalled for this, that, and the other thing. Don't get me wrong, I know they're only human and they make mistakes too, but it makes you wonder how this all gets by them.

    Answer by Nanixh at 9:49 PM on Feb. 22, 2011

  • I assume the the FDA is stretched . . . sets guidelines for plants but only randomly visits. ALso, I think they test "batches". SOme batches could be okay, others contaminated.

    I wish we had a better system.

    Answer by ImaginationMama at 4:26 PM on Feb. 22, 2011

  • Hello, they can't do anything till it looks like something needs to be done. They don't go in and test every batch of everything that is made.

    Answer by itsmesteph11 at 6:00 PM on Feb. 22, 2011

  • It looks as though the FDA knew about the contamination for quite a long time. It's cool though, itsmesteph, if you don't mind your family being at risk. I guess some people just have higher expectations for their tax dollars. This probably happens every day.

    Comment by Anonymous (original poster) at 8:33 PM on Feb. 22, 2011

  • They have to crack down on supplements and such, no time to look into things that do have an FDA pass...

    I am so sorry about this child, how absurd to get an infection from an alcohol wipe, it shouldn't be possible...

    Answer by agentwanda at 9:47 PM on Feb. 22, 2011

  • Seems like everytime we turn around there's another recall. Too bad a baby had to die before the FDA finally stepped fwd. Tylenol recalled alot of their products as well.

    Answer by Kathy675 at 12:42 AM on Feb. 23, 2011

  • I'm guessing FDA oversight is one of the governmental agencies being trimmed back ...

    Answer by tasches at 12:34 PM on Feb. 23, 2011