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.
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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- ORA Targets CAPA Effectiveness Check Deficiencies
Find out how FDA investigators determine if a company’s Corrective and Preventive Action (CAPA) system is adequate.
- Many Device Cleaning Validation Programs Need Work, FDA Investigator Says
Did you know that cleaning and sterilization are two different processes? Learn why your cleaning validation program may need to be updated.
- Process Capability in Focus in FDA Device Inspections
When an FDA investigator finds issues with process capability, this often points to other areas of potential concern.
- Best Practices for Responding to a Medical Device FDA 483
If you receive an FDA form 483, what is the most effective way to respond? An ORA compliance officer discusses FDA’s 483 response review process.
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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