top of page

FDA Guidance regarding Onsite Inspections during COVID19 (Q&A) - USA

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry", clarifying some of the plans to take when the agency cannot conduct an onsite inspection of a facility.

FDA acknowledges the fact that on-site inspection activities are "limited due to factors including travel restrictions" and "intends to continue using alternative tools, when appropriate, to evaluate facilities".


The document explains what FDA deems as "mission-critical" and how it will ensure the quality of imported products while inspections are limited.

US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID


Check out these Inspection Guides by FDA

  • Biotechnology

  • Computer Issues

  • Devices

  • Drugs

  • Foods & Cosmetics

  • Miscellaneous

These documents are reference material for investigators and other FDA personnel.

3 views0 comments
I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page