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FDA Enforcement — February 2021 Report

Automated analysis of 1 items from public government data sources. Updated daily.

Summary

1
Total items
1
High impact
0
Medium impact
0
Low impact

High-impact items this period

Marci Beauty LLC
Adulterated device without IDE/PMA approval
Why: Distribution of unapproved medical device without investigational exemptions  ·  Feb 02  ·  Impact: HIGH

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Data sourced from public government APIs. AI analysis via Claude Haiku. Full methodology →