We see a lot of people, all throughout the world, purchasing 483s from our FDA document store.  For example, this month customers came from Ireland, India, and China.  Here are some of the tools of the trade they purchased from us:

  1. FDA 483 Nobel Procera Services – Quebec, Canada – 12 Sep 2013
  2. FDA 483 Catalent Pharma Solutions – Saint Petersburg, FL – 25 Mar 2016
  3. FDA 483 Wockhardt – Karodi, India – 30 Jul 2013
  4. FDA 483 Sandoz Industrial Products – Palafolls, Spain – 12 Mar 2010
  5. FDA 483 Mylan Labs – Dhar, India – 14 Mar 2014
  6. FDA 483 Warner Chilcott Company – Manati, PR – 03 Oct 2016
  7. FDA 483 Professional Arts Pharmacy – Baltimore, MD – 23 Mar 2016
  8. FDA 483 Patheon – Manati, PR – 21 Jun 2016
  9. FDA 483 Mylan Pharmaceuticals – Morgantown, WV – 18 Nov 2016
  10. FDA 483 American Specialty Pharmacy – Dallas, TX – 05 Aug 2015
  11. FDA 483 Philips Medical Systems – Cleveland, OH – Aug 18 2017
  12. FDA 483 Eli Lilly and Company – Indianapolis, IN – 06 Dec 2013
  13. FDA 483 Philips Medical Systems – Cleveland, OH – 28 Jan 2014
  14. FDA 483 Meta Pharmacy Services – Las Vegas, NV – 20 Dec 2016
  15. FDA 483 Hisamitsu Pharmaceutical – Utsunomiya, Japan – 20 Jan 2017
  16. FDA 483 Bushu Pharmaceuticals – Gun, Japan – 02 Feb 2017
  17. FDA 483 BioMarin Pharmaceutical – Novato, CA – 17 Apr 2014
  18. FDA 483 PRACS Institute – Fargo, ND – 06 Aug 2012
  19. FDA 483 Hisun Pharmaceutical – Hangzhou, China – 27 Oct 2016
  20. FDA 483 Sun Pharmaceutical Industries (prev. Ranbaxy Toansa) – Punjab, India – 25 Nov 2011
  21. FDA 483 Dr. Reddy’s Labs – Rangareddy, India – 17 Jun 2015
  22. FDA 483 Aurobindo Pharma – Hyderabad, India – 10 Jul 2015
  23. FDA 483 Dishman Pharmaceuticals and Chemicals – Lodariyal, India – 13 Feb 2015
  24. FDA 483 Mylan Labs – Bangalore, India – 16 Mar 2016
  25. FDA 483 Microbiological Consultants – Huntington, WV – 07 Nov 2014
  26. FDA 483 Lonza – Walkersville, MD – 06 Feb 2017
  27. FDA 483 Bell-More Labs – Hampstead, MD – 13 Mar 2015
  28. FDA 483 Aurobindo Pharma Limited (Unit I) – Hyderabad (Medak District), India – 25 Oct 2016
  29. FDA 483 Cook Pharmica – Bloomington, IN – 17 Feb 2017
  30. FDA 483 Catalent – Brussels, Belgium – 28 May 2015

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 us if you ever have questions at [email protected].

Subscribe to our monthly newsletter for regulatory and quality insights and developments.