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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

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Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

Facility Controls: Ensuring that manufacturing facilities are designed, maintained, and operated to prevent contamination, errors, and defects. Strategies include: Compliance with Local Regulations: Adapting labeling to meet the specific requirements of each market, including language translations, symbols, and regulatory information.