FDA 483 and EIR Form Monitoring Service

FDAzilla Intelligence Monitoring Service

The FDA is watching you.  Let FDAzilla help you watch them.

 

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

  • 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.
  • Reporters are increasingly referring to specific FDA 483 reports in breaking news stories, sometimes even quoting directly from the actual 483.
  • Hedge fund and investment bank analysts have been calling us with much more frequency, asking for 483s as they now weigh manufacturing excellence in their investment risk profile. Some 483s obviously play into pending clinical filings/approvals.
  • 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.

Through the FDAzilla Intelligence Monitoring Service (FIMS), FDAzilla monitors the manufacturing facilities of your choice for FDA 483 reports and FDA EIRs. By proactively scanning all FDA inspector activity globally every month, FDAzilla identifies any 483s or EIRs that occur at your selected facilities within 45 days of occurrence. These documents are then requested on your behalf and made available to you and any of your colleagues as quickly as possible.

This keeps you ahead of the curve, gaining access to the latest problem area trends of your competitors as well as specific intelligence on FDA inspector tendencies. This also enables you to learn from others’ mistakes, motivate your team toward compliance, and strategically allocate efforts to the most pressing areas. It’s like NFL coaches watching film on opposing teams to learn their tendencies and habits. This information is invaluable for prep strategy & “game day” tactics, when the FDA knocks on your door again.

Did you know that if you request documents from the FDA – this information is public information? By utilizing FIMS, you will gain access to FDA 483 and EIR reports faster than anyone else in the industry, you’ll get exactly the 483s you want, and do so completely anonymously to the public.

Join other major pharmaceutical companies who have already signed up for this service – the FDA is already watching you. Let FIMS help you watch them as well.

Email Tony Chen if you’d like more information – tony@fdazilla.com

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

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