A new era for FDA GMP inspection preparation and regulatory intelligence has arrived.
FDAzilla services have been utilized by hundreds of clients, ranging from small pharmaceutical firms to investment banks to Fortune 500 companies in every FDA-regulated industry. Cited by major media outlets such as MSNBC, WSJ, and the Boston Globe, FDAzilla.com has been viewed more than 1 million times per year.
In 2010, the FDAzilla team spotted the growing need for trustworthy and timely FDA intelligence. By simplifying the complicated world of FDA documents and databases, FDAzilla provides data analytics, intelligence services, and inspection documents to FDA-regulated companies seeking an advantage. Equipped with this unrivaled information, FDAzilla customers can effectively:
- Prepare for FDA inspections
- Perform due diligence on partners and competitors
- Save time and money
- Minimize the risk of an FDA GMP enforcement action
No, we are not associated with the FDA. We obtain data and documents from the FDA (i.e., 483s, Warning Letters, etc.) and process that information as tools for understanding FDA inspection and enforcement trends.
You can contact us here.
483s, EIRs, 483 Response Letters, Inspector Profiles, and Site Profiles. Upon purchase, every document offered from the store is provided immediately and electronically.
The FDAzilla store (https://fdazilla.com/store/483s/) is available to everyone to purchase the variety of documents listed above. Customers can buy as few or as many individual 483 PDFs, Inspector Profiles, etc. as they like. The PRO website (https://pro.fdazilla.com) can only be accessed by customers who have paid for a subscription to one of our services.
To find out more about these services, please email [email protected].
We request new 483s from the FDA every month, and, subsequently, we're able to add almost 150 new reports to our store each month. We are currently considering a custom-order system that allows customers to purchase a 483 that is not in stock.
If you would like us to contact you when our pre-order system is live, we would be happy to notify you when it is ready. Just let us know at [email protected].
No, Inspector Profiles do not come with 483 PDFs. However, if you would like help choosing a 483 that would best complement your purchased Inspector Profile, feel free to initiate a chat or e-mail us at [email protected].
Our database goes back to 2000 and is updated every month.
If you are interested in one of our subscriptions, please contact [email protected]. This helps us make sure you get the data you need.
It’s true that the FDA releases FDA 483s on their ORA FOIA Reading Room. However, these represent only the most frequently requested 483s. In fact, if you look over the years, there are probably close to 100,000 FDA 483s sitting somewhere on an FDA server. They release only a few a week.
FDAzilla requests many additional FDA 483s from the FDA. Our database has 8,000+ FDA 483s, one of the largest in existence. We then utilize proprietary software to tag each FDA 483 by inspector, inspection, site, inspection date, and other relevant data elements. This tagging enables you to search 483s by any of these data elements in the FDAzilla 483 store.
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We accept all major credit cards (US and international) and Paypal. If you are having any problems, please contact [email protected] for alternative payment and fulfillment options.
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