Post by i-Pharm GxP

In 2025, the FDA issued 135 inspection-based warning letters, the highest in at least four years, and part of a trend that shows no sign of slowing. The violations driving them? The same four cGMP requirements that have topped the list every year since 2021. In March 2026, the FDA published its first-ever draft guidance on how drug manufacturers should respond to Form 483 observations. The comment period closed on 8 May, and a final version is now expected. In this month's GxP Insights, we break down what it all means for US pharmaceutical manufacturers: → Why the response to a Form 483 matters → The enforcement data behind the draft guidance → What the FDA now expects from a credible response → How the industry has pushed back → The skills in growing demand --- Want more insights like this? ✅ Subscribe to GxP Insights for monthly deep dives into key topics across Medical Devices, Biologics, Cell & Gene Therapy, and Sterile/Aseptic Manufacturing ✅ Follow i-Pharm GxP for updates on life sciences regulation, talent demand, and market activity #FDA #Pharma #GMP #QualityAssurance #Compliance #LifeSciences