The FDA Group's Insider Newsletter

The FDA Group's Insider Newsletter

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Three Warning Letters, One Message: FDA Isn't Buying Your Corrective Actions
Three CDER warning letters posted March 10 expose a shared enforcement theme: inadequate responses, systemic quality failures, and a regulator losing…
 • The FDA Group
FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three…
When a CAPA's effectiveness data shows the corrective action isn't working and the CAPA stays closed anyway, the quality system has a structural…
 • The FDA Group
5 GMP Audit Questions That Keep Catching Pharma Teams Off Guard
A few recent field notes from our auditors and mock inspectors.
 • The FDA Group
The ICH Just Released Its Overhauled Stability Guideline for Consultation
Here's a detailed breakdown plus a few questions for self-assessment.
 • The FDA Group
What Our Auditors Are Finding Lately: 8 Trends Across GMP and GCP Audits (Q2 2025)
A look back at our recent audit reports and mock inspections.
 • The FDA Group
What Our Auditors Are Finding Lately: 8 Trends Across GMP, GLP, ISO, and CSV Audits (Q1 2026)
A look back at our recent audit reports, supplier qualifications, mock inspections, and internal assessments.
 • The FDA Group
10 Takeaways from FDA's QMSR Town Hall on Risk-Based Inspections
A quick breakdown of FDA's April town hall on risk-based medical device inspections under the new Compliance Program 7382.850.
 • The FDA Group
What Our Auditors Are Finding Lately: 10 Trends Across GMP, GCP, ISO, and GDP Audits (H2 2025)
A look back at our recent audit reports, mock inspections, gap assessments, and supplier qualifications.
 • The FDA Group
A Few Quick Tips for CAPA System Success in 2025
CAPA remains a top compliance concern year after year — one we see all the time in audits. Here are five practical steps you can take right now to…
 • The FDA Group
FDA Uncovers Critical Manufacturing Violations at Chinese API Makers
The FDA put two Chinese API makers on import alert after failed inspections.
 • The FDA Group
[April 2026] FDA Form 483 Response Guidance, Weight Loss Device Framework + AI-Driven Device Warning Letter
Watch now (57 mins) | The FDA finalizes how to respond when inspectors hand you a 483, publishes a premarket framework for weight loss devices, and…
 • The FDA Group
56:40
20 Questions Your Quality Team Should Be Asking Right Now (Part 1/2)
A follow-up to our recent H2 audit trends report that operationalizes that data into practical questions for self-assessment.
 • The FDA Group
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