Enforcement

Breakdowns of enforcement actions, trends, and what they signal for regulated organizations.

Open filters
Search
Tags
Author
Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
Subscribe to our Newsletter
Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
Subscribe
Enforcement

FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants

June 2, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 5/17/20

May 26, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 5/3/2020: 42 Concern COVID-19 Claims

May 12, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 4/27/2020: HCT/P

May 6, 2020
Redica Systems
No items found.
Enforcement

Roundup of Q1 2020 Food and Dietary Supplement Warning Letters

April 29, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 4/20/2020: Untitled Letter to Stem Cell Firm

April 27, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 4/13/2020: Compounding Pharmacy

April 21, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 4/6/2020: Devices, BIMO

April 14, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 3/30/2020: Pharma, Device, GLP, and Compounding Pharmacy

April 7, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

March 31, 2020
Redica Systems
No items found.
Enforcement

EMA Announcements Regarding Nitrosamine and MDRs

March 27, 2020
Redica Systems
No items found.
Enforcement

COVID-19 Briefing: Covington & Burling Teleconference

March 17, 2020
Redica Systems
No items found.
Enforcement

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

March 10, 2020
Redica Systems
No items found.
Enforcement

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

March 3, 2020
Redica Systems
No items found.
Enforcement

The Importance of Monitoring Import Alerts

February 26, 2020
Redica Systems
No items found.
Enforcement

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

February 11, 2020
Redica Systems
No items found.
Enforcement

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

February 4, 2020
Redica Systems
No items found.
Enforcement

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

January 21, 2020
Redica Systems
No items found.

Other Resources