Enforcement Posts
Enforcement
FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer
Barbara W. Unger
February 23, 2021
Enforcement
OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns
Redica Systems
January 13, 2021
Enforcement
FDA Warning Letters: 11/22/2020 & 12/1/2020
Barbara W. Unger
December 8, 2020
Enforcement
FDA Warning Letters Week Of 11/8/2020: Process Validation Failures
Barbara W. Unger
November 17, 2020
Enforcement
Warning Letters Week Of 11/1/2020: Hold Times
Barbara W. Unger
November 10, 2020
Enforcement
Warning Letters Week Of 10/25/2020: Cleaning Validation
Barbara W. Unger
November 3, 2020
Enforcement
Warning Letters Week Of 10/18/2020: Misbranded Biologics
Barbara W. Unger
October 27, 2020
Enforcement
Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy
Barbara W. Unger
October 20, 2020
Enforcement
Warning Letters 10/4/2020: Medical Device Adverse Events
Barbara W. Unger
October 13, 2020