Playback speed
Share post
Share post at current time

[May 2024] FDA Revises Remote Mfg Guidance to Include Expanded Powers, Warns Medtech About Data Integrity with Third-Party Labs + Warning Letter Breakdown

We examine the FDA’s revised guidance on remote manufacturing assessments, highlight the latest warnings on data integrity for medtech firms, and analyze a warning to an orthopedic implant firm.

Welcome to Insider issue #25.

And a very warm welcome to the 734 new life science professionals who joined last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.

The FDA Group's Insider Newsletter is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.

Our pharma feature delves into the FDA’s revised draft guidance on remote manufacturing assessments (RRAs), providing an updated approach to voluntary and mandatory remote regulatory assessments. Released towards the end of January, this guidance outlines how the FDA will utilize RRAs to understand biopharma manufacturers better and support approval decisions. It covers when and how RRAs will be conducted, the responses expected from companies, and the potential consequences of refusing a remote inspection. We given a detailed breakdown of the guidance, practical preparation advice, and specific compliance tools.

Our device/medtech feature highlights the FDA’s recent warning to medtech sponsors and manufacturers regarding potential data integrity issues with third-party testing laboratories. The FDA has observed an increase in unreliable data submissions, particularly from labs in China and India. This article underscores the importance of vigilance and oversight in ensuring data integrity. We provide key insights from the FDA's warning, detailed recommendations for ensuring data accuracy, and steps for setting up independent testing programs.

Lastly, our warning letter breakdown examines a recent FDA warning to an orthopedic implant maker for packaging deficiencies that could lead to faster degradation of implants. The warning letter offers critical lessons in handling CAPA, CGMP, and MDR. We thoroughly analyze the issues identified by the FDA and specific, actionable recommendations for quality teams to prevent similar compliance failures.

Download this content to use any way you’d like:

Watch with a 7-day free trial

Subscribe to The FDA Group's Insider Newsletter to watch this video and get 7 days of free access to the full post archives.

The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
The FDA Group