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 10/18/2020: Misbranded Biologics

October 27, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy

October 20, 2020
Redica Systems
No items found.
Enforcement

Warning Letters 10/4/2020: Medical Device Adverse Events

October 13, 2020
Redica Systems
No items found.
Enforcement

Q2 2020 Food and Dietary Supplement Warning Letters

October 12, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 9/27/2020: Aseptic Process Issues

October 6, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 9/20/2020: Quality Unit Failures

September 29, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 9/13/2020: Lack of Validation

September 22, 2020
Redica Systems
No items found.
Enforcement

Highlights from Recent FDA Inspections of Vendors/Suppliers

September 16, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 9/6/2020: Data Integrity Failures

September 15, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 8/30/2020: Adulterated Products

September 8, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week Of 8/23/2020: Sterility Assurance Failures

September 1, 2020
Redica Systems
No items found.
Enforcement

Enforcement Spotlight: Retests Prove Key Data Integrity Concern

August 11, 2020
Redica Systems
No items found.
Enforcement

Warning Letters 07/26/20: Testing into Compliance

August 3, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 07/19/20: Unapproved New Devices

July 28, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 07/05/20: Supplier Qualification

July 14, 2020
Redica Systems
No items found.
Enforcement

Warning Letters 06/28/20: Unapproved Vendors

July 7, 2020
Redica Systems
No items found.
Enforcement

FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection

June 30, 2020
Redica Systems
No items found.
Enforcement

Warning Letters Week of 06/14/20: Data Integrity

June 23, 2020
Redica Systems
No items found.

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