South Korea-based Neo Vision received a warning letter for failing to establish proper design controls, monitor production processes, maintain device history records, and other violations. Read More
OMT landed a Form 483 citing its handling of complaints, design controls, and other issues. Read More
A bipartisan bill introduced last week in the Senate seeks to harmonize FDA’s medical device inspections process worldwide by eliminating variations between countries. Read More
Gynetech received a Form 483 for untimely reporting procedures, risk analyses that were not performed, and 12 other observations. Read More
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