If you haven’t been to FDAzilla.com in a while, then you’ve come to the right place. If any part of your job involves preparing your company for FDA GMP inspections, let me take you on a quick tour of some tools and resources that you might find useful!  Take 4 minutes and check out these 4 things:

  1. DECREASE YOUR RISK WITH DATA: Companies like P&G, Altria, AbbVie, Novartis, Astellas, and many others now count on accessing a new data analytics tool called Enforcement Analytics. Imagine being able to “google” FDA inspections and inspectors. Here’s a short video.
  2. INSPECT YOUR INSPECTOR: FDA inspector coming on Tuesday? Or worse yet, she’s in your conference room right now?  You can get her inspector profile, which includes her most frequently cited CFR code, most frequent co-inspectors, enforcement metrics, and inspection history. In just the last few weeks, customers from 3 continents have purchased these in preparation for an upcoming (or current) inspection.
  3. READ FRESH INSIGHTS: The blog you’re on now is a treasure trove of resources and insights from me (Tony Chen, CEO of FDAzilla) and Barbara Unger, GMP Quality Expert, who has been in your shoes. Why not start here – our 14 most popular posts of all time. If you feel that getting needed info is like finding a needle in a haystack (or drinking from a firehose!), let us do the work for you. Get our comprehensive, succinct weekly synthesis of the latest GMP regulations, guidelines, enforcement actions, and developments here.
  4. GET 483s (AND NOW EIRs): The FDAzilla store houses 7,000 483s, with hundreds added every month. We’ve also just added 2,000 EIRs and 150 483 response letters. If you’re a heavy 483 user, you should also consider our 483 service.

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, Inspector Profiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact Ben if you ever have questions at ben@FDAzilla.com.