Triad recall moves Form 483 to limelight

The recent Triad recall of alcohol wipes is destined for greatness. It will be remembered as the recall that introduced the public to the FDA Form 483 inspection report.

In extended coverage of the recall, MSNBC explains the purpose of the 483, provides quotes from it, and shows that the report can be linked to earlier inspection reports, revealing repeat violations.

Via the 483, the MSNBC audience walked alongside FDA inspectors through the Triad plant, observing the 46 instances of GMP noncompliance.

For comparison, the average count of observations in a 483 inspection report is six, says Tony Chen. He's CEO at FDAzilla.com, a website dedicated to making FDA information easier to access and understand than the FDA site. FDAzilla is cited as a source in the MSNBC story.

Chen sampled 208 Form 483s issued to biopharma companies in 2009 and 2010. He finds that the highest observation count is 21; the lowest, one. Additional stats are available in his report, Top Seven Strategies for Avoiding 483s.

The Triad recall was MSNBC's lead story on the day the news broke, ensuring great exposure. Chen is at once a beneficiary of that coverage and proof of public interest in the story. "We've had 10,000 visits from people clicking from the story to the FDAzilla site," he says via phone. His typical website traffic rate is 70,000 views per month.

- see the MSNBC story

Suggested Articles

Teva will produce its new migraine drug at a plant in Israel and more news of note.

The shortage of childhood cancer drug vincristine was front and center during the Senate hearing for Stephen Hahn, nominee for FDA commissioner.

The FDA has lambasted the Torrent Pharmaceuticals in a warning letter for making OTC meds using water tainted with bacteria.