As FDA officially resumed domestic surveillance inspections last week, your team is probably wondering what FDA investigators focus on when they conduct inspections at medical device manufacturing sites.

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Last year, Redica Systems Senior GMP Quality Expert Jerry Chapman attended the FDA/Xavier MedCon Conference where four FDA Office of Regulatory Affairs (ORA) investigators provided insights into specific issues they see during FDA inspections of medical device manufacturing sites. 

Here are some carefully curated articles covering medical device topics from those conference sessions. 

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In addition to these articles, you might find our series of articles on Inspection Readiness valuable. The video clip below features advice from Steven Niedelman, a former FDA Deputy Associate Commissioner for Regulatory Affairs, on preparing for an FDA inspection.

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