Report – First FDA Warning Letter to Excipient Manufacturer Provides Lessons

Report – Intas Pharmaceuticals’ Troubles with FDA Continue

Report – Expert Analysis: 22 years of FDA Drug GMP 483s

Report – Analysis of FDA 483s Issued to Excipient Manufacturers Since 2000

Report – Analysis of FDA Drug GMP Warning Letters for FY2022

Report – Breaking News: The First FDA Warning Letter to an Excipient Manufacturer

Report – Insights on Quality from FDA Leaders

Report – Wipe it With a Cloth? Particle Contamination Risks of Cloth Wipes

Report – 4 GMP Case Studies Including FDA Findings and Concerns

Report – Analysis of 2021 U.S FDA 483 GMP Observations

Report – Yes, Warehouses that Store and Distribute FDA Regulated Products Must Comply with Relevant GMPs

Report – UDI-related Issues in Form 483s: Where Should You Focus Mitigation Efforts?

Report – Analysis of FDA Drug GMP Warning Letters for FYs 2020 and 2021

Report – GMP Issues With COVID Vaccines and Drugs are Not New Concerns

Report – The Current Pharmaceutical Quality Landscape

Report – An In-Depth Look at Combination Product Regulations

Report – CDMO Comparison Report

Report – 5 GMP Case Studies

Report – 483 Data Integrity Observations

Report – Analysis of 2019 UK MHRA GMP Inspection Findings

Report – FDA FY2020 Drug Observations and Trends

Report – FDA Inspection Landscape Mid-2020 and Virtual Inspections

Report – State of Pharmaceutical Quality

Sample – 510(k)