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EU vs FDA Audit
What are the major differences between EU and FDA Audit?
Which one is more tough to face?
FDA and EU regulations concerning clinical research, manufacturing and quality, and post-marketing surveillance are highly similar but their legal frameworks and drug approval pathways are slightly different.
The FDA is the principal governing agency in the United States responsible for regulating medications, medical devices, veterinary medicines and food, tobacco products, animal products, cosmetics, most human foods, and other miscellaneous items. The organization covers a broad range of products for which it can make regulatory decisions.
Comparatively, the EU (EMA) evaluates human and veterinary medicines in the European Union, Iceland, Norway, and Liechtenstein.
From my experience FDA audit is comparatively more tough than EU audit.
I refer to below article containing regulatory inspection checklist:
https://www.pharmaspecialists.com/2022/08/regulatory-inspection-checklist.html