JD Supra

FDA Issues Draft Guidance for Responses to Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of ...
JD Supra

FDA Issues First-of-Its Kind Guidance on Expectations for Drug Manufacturing 483 Responses

Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form ...
FiercePharma

Novo plant acquired in Catalent buyout faces renewed FDA scrutiny with Form 483: Stat

Despite boasting a new owner, the Indiana manufacturing plant Novo Nordisk picked up as part of its parent company's Catalent buyout last year continues to catch flak from the FDA. Novo has received ...
PharmTech

PDA 2025: FDA Experts’ Proactive Strategies for Mastering 483 Responses

FDA emphasizes a shift from checkbox compliance to a holistic, quality systems-focused approach in pharmaceutical manufacturing. Post-warning letter meetings require demonstrated implementation of ...
FiercePharma

Rentschler slapped with FDA Form 483 citing lax manufacturing procedures

Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. FDA inspectors visited ...
MD&M East

Avoid FDA 483 Warnings with Better Documentation

Good documentation is an investment. If you need convincing, all you have to do is glance at FDA 483 warning letters, which cite documentation problems with alarming frequency. The good news is that ...
PharmTech

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

FDA inspections ensure compliance with GMPs, focusing on documentation practices, SOPs, and non-conformances. Inspections can be surveillance, for-cause, application-based, or follow-up, and occur ...