Everyone breathes a sigh of relief when the FDA investigators depart.
But if they left behind a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts.
The good news is that a well-reasoned response can help a company side step a warning letter or worse. The bad news is that the agency gives you only 15 business days to pull it together.
Regulatory law expert Glenn Demby has culled the best — and some of the worst — responses the FDA has received to 483s. He’ll walk you through which responses were good and which were not, so you can make your answers the best they can be.
Glenn will show you the FDA’s exact CAPA observations in each 483 and put them side-by-side with the company’s response. You’ll see how firms handled particular issues, especially the tone and language they used.
If your company hasn’t received a 483 with CAPA observations, you can match your systems with those that have and ensure that all gaps are closed before your next inspection.
This management report will provide the following:
Remember, you have only 15 days to respond to a 483. Most of that time will go toward bringing your CAPA program into compliance. Don’t waste a second trying to figure out how to communicate those plans in a way that will convince the FDA you are focused on improvement and committed to quality. Learn from those who have been there.
PDF Edition — $397
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.