The first part of the month was relatively quiet, but then things really start hitting the fan last week. Here are some of the latest stories related to FDA 483s:
- Of course, the big story of the month is Ranbaxy. FiercePharma reported that it may have been a 483 that explains why Ranbaxy did not get blockbuster Diovan to market. Ranbaxy declined to comment to FiercePharma “about whether a Form 483 had been issued for the plant”. Our records show a few 483s issued to Ranbaxy, including the facility in question in northern India, at FDAzilla’s 483 searchable listing. This story was widely reported (articles in Reuters, Business Standard, First Post, Money Control, Economic Times, and of course, FiercePharma)
- CNBC did a feature story/video of Intuitive Surgical on their key product line – the Da Vinci Surgical Robot. Basically, the FDA claims that Intuitive Surgical “broke procedure” by alerting customers before regulators about a minor “tip cover” issue. 2 things are interesting to me about this article: (a) 483s are mentioned in the 2nd sentence of the article and (b) there was a correction at the end of the article that reads, “This article has been revised to clarify the nature of the FDA’s letter to Intuitive Surgical.” Very likely, this had to do with how the reporters read, initially understood and portrayed the FDA 483. Looks like the Wall Street analysts understood how to put these 483s into context, though – 2 such analysts defended the company and re-iterated their “buy”/”outperform” rankings.
- 10 Takeaways from FDA’s Warning and Untitled Letters – great write-up by Alexander Gaffney. Alex and the rest of the RAPS team read all these 2013 letters to date and found some interesting themes. From a lack of toilet paper to equipment sizing/design to bugs, there is something for everyone.
- IntelliCell BioSciences proactively lets the world know that it received a FDA 483 – less than 2 weeks after the end of the inspection. Through a press release. A new wave of transparency or a random one-off? My guess is the latter.
- The FDA Enforcement Funnel by Oliver Yu @ Zymergi. Great visual of how it all works. Speaking of the funnel in action…
- FDA 483s lead to FDA Warning Letters. Take it to the bank. Note the different timeframes below, though most warning letters come 3-9 months after the 483s of note.
- Alexion. FDA 483 in August 2012. Warning Letter in March 2013. “It appears that you have not implemented a robust quality system at your firm”
- West-Ward. FDA 483s in 2012, 2010, and 2008 (not clear if these related to the plant, as these were addressed to corporate). Warning Letter in February 2013 – “lacks sufficient corrective actions”
- Baxter. FDA 483 in November 2012, and then in March/April 2013. Warning Letter in May 2013 – “your response is still deficient.”
- Fresenius Medical Care. FDA 483 in December 2012. Warning Letter in March 2013
- Lisa Laser Products OHG FDA 483 in October 2012 . Warning Letter in May 2013 – “We reviewed your firm’s response and conclude that it is not adequate”
- Edward Lifesciences. FDA 483 in February 2013 . Warning Letter in May 2013 – “We cannot determine if your corrective actions are adequate at this time”
- RPG Life Sciences. FDA 483 in November 2012. Warning Letter in May 2013 – “We highly recommend that you hire a third party auditor” and “lack sufficient corrective actions”
What hit your radar this month?
- FDA 483s store – instant, anonymous access to 483 PDFs
- Free, searchable list of 5 years of 483s
- The FDA conducted 40,000 inspections in 2012