Reports Posts
Reports
Report – Analysis of FDA 483s Issued to Excipient Manufacturers Since 2000
Jerry Chapman
March 1, 2023
Reports
Report – Analysis of FDA Drug GMP Warning Letters for FY2022
Barbara W. Unger
January 3, 2023
Reports
Report – Breaking News: The First FDA Warning Letter to an Excipient Manufacturer
Barbara W. Unger
December 28, 2022
Reports
Report – Insights on Quality from FDA Leaders
Jerry Chapman
November 7, 2022
Reports
Report – Wipe it With a Cloth? Particle Contamination Risks of Cloth Wipes
Redica Systems
August 15, 2022
Reports
Report – 4 GMP Case Studies Including FDA Findings and Concerns
Redica Systems
June 1, 2022
Reports
Report – Analysis of 2021 U.S FDA 483 GMP Observations
Barbara W. Unger
May 2, 2022
Reports
Report – Yes, Warehouses that Store and Distribute FDA Regulated Products Must Comply with Relevant GMPs
Barbara W. Unger
March 4, 2022
Reports
Report – UDI-related Issues in Form 483s: Where Should You Focus Mitigation Efforts?
Mark Agostino
February 23, 2022