JoNel Aleccia and the folks at MSNBC.com have dug in deep on news of the FDA’s Jan. 5 recall of tainted alcohol wipes, spurred on by the death of a Texas toddler and complaints from across the country. Aleccia’s findings seem to indicate that, more than a month after the recall, the case of Triad Groups’ trainted products and related failures of FDA oversight may run far deeper than the original notice implied.
Aleccia’s been helped in the follow-up investigation by unofficial access to FDA records, validated by outside sources, that indicate inspectors detected problems in 2009, and again in 2010, but didn’t act until this year’s recall.
Documents show that FDA officials expressed concerns following visits to the Triad plantfrom July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care.
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The inspection documents, known as FDA Form 483s, were obtained by msnbc.com from a confidential source and confirmed by FDAzilla.com, an independent Web site that monitors the FDA. Copies of the documents were sent to the FDA for review; the agency did not deny their authenticity.
For a thorough roundup of all the points at which warnings surfaced, or at which the FDA could have intervened, check out Aleccia’s full report.
Speaking of FDAzilla.com, it might be a site worth checking out if you’re interested in the FDA’s activities. It’s free and says it has “made millions of pages of FDA data (MAUDE, devices, drugs, 483s listing, FDA employees) more usable and searchable.” The FAQ says most of its data is automatically updated nightly from files posted on FDA.gov.
