INSPECTION MONITORING

Turn the tables. Watch the FDA.

Want to gain a competitive advantage through speed and precision? FDAzilla's Inspection Monitoring Service (IM) delivers the exact 483s and/or EIRs you need faster than anyone else. Just specify the facilities you want to follow, we'll do the work of monitoring their inspections and tracking down relevant documents.

FDAzilla Inspection Monitoring Overview Most of you know who your competitors are, and are aware of sites whose manufacturing processes resemble your own. Learning from their mistakes and successes is key to your next successful FDA inspection.

What if you could know - within a month - when your competitors' sites were inspected by the FDA? Imagine having access to their inspection documents (483s and EIRs) and getting the latest insights into the FDA areas of focus. That’s what Inspection Monitoring is all about.

How it Works

THE PROCESS: FDAzilla monitors the manufacturing facilities of your choice for FDA 483 reports and EIRs. By proactively scanning all FDA inspector activity globally every month, FDAzilla identifies any 483s or EIRs issued to your selected facilities within 45 days of their occurrence. These documents are then requested on your behalf and made available to you and any of your colleagues as quickly as possible. Usually, you will be among the first to obtain these documents from the FDA.

YOUR PRIVACY: Did you know that if you request documents from the FDA, the request is public information? By utilizing Inspection Monitoring, you can gain access to FDA 483 and EIR reports, while retaining complete anonymity.

Your Advantage

Inspection Monitoring keeps you ahead of the curve, providing you with access to the latest problem area trends of your competitors as well as specific intelligence on FDA inspector tendencies. This also enables you to:

  1. Learn from others' mistakes
  2. Motivate your team toward compliance
  3. Strategically allocate efforts to the most pressing areas

It's like football coaches watching film on opposing teams to learn their tendencies and habits. The information provided by Inspection Monitoring is invaluable for both prep strategy and "game day" tactics, when the FDA knocks on your door again.

Join the other major pharmaceutical companies who have already signed up for this service. The FDA is already watching you; let us help you watch them as well.

The Rise of 483s and EIRs

We've talked to a lot of people who are seeing increased attention on FDA 483s.

  1. Industry professionals are looking to gain an edge as they prep for their next FDA inspection and to size up competitors and/or potential partners.
  2. Reporters are increasingly referring to specific FDA 483 reports in breaking news stories, sometimes even quoting directly from the actual 483.
  3. Hedge fund and investment bank analysts have been calling us with much increased frequency, requesting 483s which they are now using to weigh manufacturing excellence in their investment risk profile. Some 483s obviously play into pending clinical filings/approvals.
  4. Law firms are asking us more informed, specific, and detailed questions about 483s, possibly looking to defend (or initiate) class-action lawsuits.

The time to proactively gain intelligence from your most relevant FDA 483s is now.

Establishment Inspection Reports (EIRs) are also being requested more frequently because companies are interested in insights that are not available through 483s. The ability to read through the “play-by-play” of each inspection day provides deeper insight into the FDA's processes, inspectors, and areas of focus.

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