[b]Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year. In 2010, the FDA issued 10,407 483s, breaking the previous high-water mark of 9,666 in 2009. Through June 30, 2011, the FDA has issued 5,547 483s, approximately 100 more 483s than the same time period in 2010, roughly a 2% increase.
This begs the question – is more 483s better? Is the nation safer with more inspectors pounding the pavement? Think about this – 10,000 483s per year – that’s one 483 every 52 minutes.
This has been a notorious year for this obscure, technical document known as the FDA Form 483. In February, MSNBC reporter JoNel Aleccia broke a front-page story on the now-infamous “tainted alcohol wipes” made by the Triad Group that has led to 2 recalls, 2 lawsuits, an FDA investigation, and certainly more still to come.[/b]