Tag Archives: recalls

MSNBC: FDA had concerns 2 years before alcohol wipe outbreak, didn’t act

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

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.

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.

Wrestling with the FDA recall e-mail avalanche

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

NPR’s April Fulton recently blogged about a phenomenon familiar to anyone with a subscription to the FDA’s recall e-mail list, or their RSS feed, or their Twitter account: a late rush of random recall messages that would require a prohibitive amount of time to sort and research. fda-recallsFor example, in a two-minute span on June 15, @FDArecalls on Twitter buzzed with messages about multivitamin labels, fish, organic chocolate peanuts, white peppers and soy sprouts. Fulton also notes that many of the notices come out late in the day.

She proposes some sort of flagging or rating system to make it easier to figure out which stories are big deals and which aren’t. She may be on to something. The FDA could make these releases more accessible and useful for journalists and consumers. At the very least, it should be possible to explain the location and magnitude of the public health danger in a way that could be understood at a glance.

What other tips or tricks help you figure out which recalls are relevant to your readers? Do you have suggestions as to how the FDA could makes its releases more accessible or useful? Let us know.