Postmarket Medical Device Surveillance at CDRH: Part I

Signal Detection and Management At the time a medical device is approved or cleared, it has a

Best Practices for Responding to a Medical Device FDA 483

When a 483 is issued to a medical device company after an inspection, how should the company respond? What

EU MDR and Economic Operators for Medical Devices

In the context of the EU medical device regulation (EU MDR), what is an “economic operator” and why is

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.

FDA Warning Letters: 11/22/2020 & 12/1/2020

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter

How Small Pharma Firms Can Prepare for a GMP Inspection

[Editor's Note: This post has been updated; originally published on June 13, 2019.] Preparing for GMP

Part II: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: This is Part II of an analysis of the FY2019 UK MHRA GMP deficiencies by Redica Systems

Part I: An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

[Editor's Note: Below is Part I of an analysis of the U.K. MHRA GMP deficiencies for 2019. Part II will

Webinar – Panel Discussion Changing Medical Device Regulations

Webinar – A.I. for Quality and Compliance Teams

Webinar – Human Factors – Compliance and Applications

Report – An In-Depth Look at Combination Product Regulations

Report – 2019 Human Tissue and Cell Therapy Observations

Report – CDMO Comparison Report

Assessment – Investigator Snapshot

Assessment – Peer Benchmark Report

Assessment – CFR Trend Report