Enforcement

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

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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
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Regular posts covering guidance changes, inspection findings, data methodology, and Redica product updates.
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Enforcement

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

January 14, 2020
Redica Systems
No items found.
Enforcement

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

December 23, 2019
Redica Systems
No items found.
Enforcement

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

December 17, 2019
Redica Systems
No items found.
Enforcement

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

December 10, 2019
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 11/24/2019: Repackaging and CBD Products

December 3, 2019
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 11/17/2019: Torrent (Again) and Failing Water Systems

November 26, 2019
Redica Systems
No items found.
Enforcement

Warning Letters Week of 11/10/2019: Continued Sartan Enforcement

November 19, 2019
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 11/3/2019: Lost Documentation and Data Integrity

November 12, 2019
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 10/27/2019: Sterility and Spores

November 5, 2019
Redica Systems
No items found.
Enforcement

CTP Issues First-of-a-Kind Warning Letter to JUUL Labs

September 11, 2019
Redica Systems
No items found.
Enforcement

Review of the Office of Generic Drugs’ 2018 Annual Report

July 25, 2019
Redica Systems
No items found.
Enforcement

Why Did McKesson Receive the First DSCSA Warning Letter?

February 15, 2019
Redica Systems
No items found.
Enforcement

FDA Cites Part 11 in Clinical Trial

January 2, 2019
Redica Systems
No items found.
Enforcement

6 Features to Look for in FDA 483s

October 11, 2018
Redica Systems
No items found.
Enforcement

Part 1: FDA and MHRA’s Drug Inspection Observations

May 24, 2018
Redica Systems
No items found.
Enforcement

The Ultimate Guide to Researching Your FDA Investigator

February 9, 2018
Redica Systems
No items found.
Enforcement

FDA Sent These 11 Warning Letters for Pharma Companies | August 2017

September 20, 2017
Redica Systems
No items found.
Enforcement

FDA Sent These 6 Warning Letters for Pharma Companies | May 2017

June 14, 2017
Redica Systems
No items found.

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