Enforcement Posts
Enforcement
OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns
redica
January 13, 2021
Enforcement
FDA Warning Letters Weeks of 11/22/2020 & 12/1/2020: Water Leaks, Misleading Statements, & Adulteration
Barbara W. Unger
December 8, 2020
Enforcement
FDA Warning Letters Week Of 11/8/2020: Unapproved Cord Blood Product & No Process Validation
Barbara W. Unger
November 17, 2020
Enforcement
FDA Warning Letters Week Of 11/1/2020: Unapproved HTC/P, Hold Times, & FD&C Violations
Barbara W. Unger
November 10, 2020
Enforcement
FDA Warning Letters Week Of 10/25/2020: Cleaning Validation & Foreign Particles
Barbara W. Unger
November 3, 2020
Enforcement
FDA Warning Letters Week Of 10/18/2020: Misbranded Biologics & Pharmacy Ceases Operations
Barbara W. Unger
October 27, 2020
Enforcement
FDA Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy & Inadequate CAPAs
Barbara W. Unger
October 20, 2020
Enforcement
FDA Warning Letters Week Of 10/4/2020: Validation Failures & Medical Device Adverse Events
Barbara W. Unger
October 13, 2020
Enforcement
Q2 2020 Roundup: Warning Letters to Food & Dietary Supplement Firms
Patty Harvey
October 12, 2020