Get all the 483s you need. FDAzilla now offers an FDA 483s SUBSCRIPTION SERVICE where you can access all of our 483s any time you want throughout the calendar year. We have one of the most comprehensive libraries of 483s, with 3,500+ 483s that is updated quarterly (We anticipate bringing in at least 1,000 more in the next 12 months).
It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013: Continue reading
The government is still shut down, though the FDA is still about half-open. The question is: which half?
The government shutdown is now on day 9, with no end in sight. Based purely on our 483 sales data in the last 9 days compared to September data, we’re seeing a significant drop. It makes sense that FDA inspections have either slowed down significantly or stopped completely. It was reported earlier this week that 45% of the entire staff would be off. Continue reading
FDAzilla was mentioned in a front-page story today in the Wall Street Journal. The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.
Current and potential investors of your company may actually be reading your FDA 483.
Ranbaxy stock took a 30% hit today following an import alert issued by the FDA. The alert was reportedly issued based on serious cGMP issues at the Mohali plant from September and December 2012 483s. Ranbaxy’s other two plants in India were already barred from importing to the U.S., this third plant in India was supposed to be the model plant, paving the way to a recovery. Obviously, this is a huge blow to the company.
For more context on Ranbaxy’s tumultuous year, read FiercePharmaManufacturing’s write-up. FDAzilla has the September 2012 FDA 483 available for immediate purchase and download in the FDAzilla store.
By popular demand, we’re excited to announce that we have recently more than doubled the size of our 483 library. After painstakenly obtaining, organizing, renaming, and categorizing these documents, we now have 2,300+ 483s and counting in our library available in PDF format for immediate purchase and download. Continue reading
Today’s post is written by guest blogger Greg Hattoy. Greg is a regulatory compliance specialist and insightful industry writer at his blog, greghattoy.com. Greg takes a distinct approach to regulatory issues and shares his innovative vision for the direction of the pharmaceutical industry
As a regulatory professional, lately it has becoming glaringly apparent that the only way to be successful in a regulatory audit is to take a holistic approach to quality. Holistic can be simply defined as ‘emphasizing the importance of the whole and the interdependence of its parts’. Like holistic medicine, for a ‘healthy’ status with the regulatory agencies, a company, with all their individual components, must be firing on all cylinders in regards to compliance with the greater goal of quality. Now I fully understand this may sound like hippie nonsense, but before the incense candles, spirit crystals, and kumbaya songs come out, let me further explain this thought. Continue reading