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Redica Systems

Trends

Update: What are Pharma and Med Device Firms Doing About COVID-19?

Enforcement

Warning Letters Week of 3/1/2020: Device Design Controls

Enforcement

FDA Warning Letters Week of 2/23/2020: After 3-Week Absence, 8 to Drug and Device Firms

Enforcement

The Importance of Monitoring Import Alerts

Conference Spotlight

Part 2: Department of Justice Consumer Protection Branch Doubles in Size to Battle Fraud and Deception in the Drug and Dietary Supplement Industries

January 483s: Most Popular and Newsworthy

Enforcement

FDA Warning Letters Week of 2/2/2020: Device Repeat Deficiencies

Enforcement

FDA Warning Letters Week of 1/26/2020: HCT/P and OTC Products

GMP Compliance for Legacy Products: How to Find and Avoid Potential Quality Issues

510k – What is the FDA 510(k) Premarket Notification?

Enforcement

FDA Warning Letters Week of 1/12/2020: CMO Quality

December 483s: Most Popular and Newsworthy

Enforcement

Warning Letters Week of 1/5/2020: Data Discrepancies

Conference Spotlight

How to Talk So That FDA Will Listen, and How to Listen When They Talk: Advice That Could Be Worth Millions

November 483s: Most Popular and Newsworthy

Enforcement

FDA Warning Letters Week of 12/15/2019: Independent Assessment Requests

Enforcement

FDA Warning Letters Week of 12/8/2019: CAPAs, Complaints, and Quality Systems

Enforcement

FDA Warning Letters Week of 12/1/2019: Cell and Tissue Therapies