Top Seven Strategies for Avoiding 483s Report | Pharma/Biotech Sector
June 21st, 2011 // 6:57 pm @ jmpickett
The FDA has warned numerous times that they expect you to monitor the happenings of your peers — rather than wait for the FDA to show up to identify the same problems. You can do just that with a new resource from FDAzilla.
Price: $749
Click here to visit FDAzilla and purchase.
Enter ‘no483s’ at check out to save $200!
The inside track on cGMP 483s
Avoid cGMP-related 483s (and all of its hassles) in 2011 by learning from those who’ve been there. FDAzilla’s report goes where no other ‘how to avoid 483s’ report has gone before. We painstakingly pulled together 242 pharma/biotech 483s from the FDA – most of them from the last 2 years. We analyzed the data. We talked to numerous former FDA officials (including the former director of enforcement) and front-line experts like yourself.
After months of research, this 31-page report, full of graphs, data, and analysis, is the result. Buy it today so you can be ready for the FDA tomorrow. You’ll also get the 10 biotech/pharma 483s from 2010 that had the most observations – 108 pages worth of real-world lessons your team will want to go through with a fine-toothed comb.
Avoid the headaches
Think about all the headaches, the all-day meetings, and the angry bosses that come from getting a 483. Think about the dozens or hundreds of hours you’ll spend creating dozens of 3″ binders of documentation. And what about all the productivity you’ll lose when your team has to work for weeks on 483 responses rather than improving operations?
Even worse, just imagine the negative press that could come from one bad mistake (here’s a good example from just February 2011 of a company who didn’t adequately address their 483 problem. Front-page, lead story on MSNBC). We’ve seen some of the biggest blow-ups in the pharma industry in just the last 12 months.
For less than the cost of a single meeting with your lawyer, avoid this massive investment of time and energy. Arm yourself with the best information available on 483s – straight from the FDA’s own files
Price: $749
Click here to visit FDAzilla and purchase.
Enter ‘no483s’ at check out to save $200!
More Information:
Beyond the report, you will also get the 10 483s of 2010 that had the most observations. Purchasing these 483s from our 483s store would cost up to $390. If you purchase this report, you will get these as part of the package – all 108 pages and 150+ observations. While the report provides the overall analysis of the top 7 broad areas to focus on, these actual 483s in and of themselves will provide a great way to assess your operation’s specific vulnerabilities.
Some companies literally go through these reports, one observation at a time, checking off areas in which they are strong and “X”ing the observations in which they need to pay more attention – effectively prioritizing their action plan for improving inspection-readiness.
The list of the 10 483s with the most observations are as follows:
1. Agropharma Laboratories (March 25, 2010)
2. Beaumont Products (January 12, 2010)
3. Chemisphere Corp (March 23, 2010)
4. Cosmed Labs (January 21, 2010)
5. GMP Laboratories of America (January 13, 2010)
6. H & P Industries (April 19, 2010)
7. Hill Dermaceuticals (February 1, 2010)
8. J F Labs (January 19, 2010)
9. Levlad LLC (September 2, 2010)
10. Nexgen Pharma (March 1, 2010)
