CAPA deficiencies remain one of FDA's most reliable predictors of enforcement. What separating corrective and preventive action workflows looks like under QMSR, and what manufacturers actually need to change in their quality systems.

How complaint handling works under the QMSR: ISO 13485 clause 8.2.2, 21 CFR 820.35 record content, Part 803 MDR timelines, Part 806, and reportability scenarios.

FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.

In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a

Five months into FDA's new Quality Management System Regulation, the agency has said out loud what's actually showing up in QMSR Form 483 findings — and it's not a paperwork problem.