Category Archives: FDA Updates

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings The single biggest focus area in every QMSR inspection that MDI has participated in is not your quality manual, SOPs/work instruction, documentation structure or your terminology — it is your organizations ability to demonstrate risk-based thinking embedded throughout your entire quality

First New UV Filter Approved in Over 20 Years!

FDA Opens the Door to Sunscreen Innovation: First New UV Filter Approved in Over 20 Years! The U.S. Food and Drug Administration (FDA) has finalized an administrative order adding bemotrizinol to the Over-the-Counter (OTC) Sunscreen Monograph, making it the first new sunscreen active ingredient approved for inclusion in the U.S. OTC sunscreen framework in more

How to Respond to an FDA 483 and Warning Letter – Precautionary Measures

The FDA themselves state it is industry’s responsibility to work with investigators before they leave the company to remove all incorrect points on the 483. The FDA is also supposed to annotate the 483 concerning your corrective actions that were accomplished during the inspection. From latest experience with the new FDA investigators, this advice doesn’t

How to Respond to an FDA 483

FDA Inspections & Compliance How to Respond to an FDA 483 — and Prevent a Warning Letter A company that receives a Form 483 has one opportunity to demonstrate control, credibility, and corrective action before the FDA decides whether to escalate. This guide — written by a former FDA field investigator — shows exactly how

FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight

FDA Update PLEASE BE AWARE THAT THE FDA HAS LAUNCHED THE FOLLOWING PROGRAM. WHAT DOES IT MEAN TO YOU? FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight The U.S. Food and Drug Administration today announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources

Food Economic motivated Adulteration – Honey

The FDA posts various areas of concerns as they see them developing. We will try to provide them to you for your review and knowledge. Here is the April 13, 2026 on Food Economic motivated Adulteration – Honey The U.S. Food & Drug Administration is releasing data from a sampling assignment carried out in 2025 to test

The new QMSR regulations – and Risk Analysis

We recently participated in FDA inspections using the new QMSR (Quality Management Systems Regulations). These inspections were very interesting. One was conducted at a foreign client in China the other was in the USA. These inspections went directly to the QMSR and expected that the companies were following the new regulations. If you are already

What FDA Inspectors Are Actually Checking Under the New QMSR

FDA UPDATE What FDA Inspectors Are Actually Checking Under the New QMSR — mdi’s First-Hand Findings The FDA’s QMSR replaced the old QSR on February 2, 2026 — and if your quality system documents still reference 21 CFR Part 820 sections instead of ISO 13485 clauses, your next FDA inspection will expose that gap immediately.

FY 2026 Government Shutdown and how it will AFFECT the FDA Operations Update

FDA Update FY 2026 Government Shutdown and how it will AFFECT the FDA Operations Update As of October 1, 2025, no Fiscal Year (FY) 2026 appropriation or Continuing Resolution (CR) has been enacted for the U.S. Food and Drug Administration (FDA). As a result, the agency has entered a lapse in funding and is operating

FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products

FDA Update FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products The FDA just announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to