CDRH Inspection CPG Omits "Fatal Flaw" And Minor Nonconformities Clauses
This article was originally published in The Gray Sheet
Executive Summary
FDA's proposed policy of halting routine inspections when a serious nonconformance is identified has been removed from its final compliance program guide for medical device audits, released Feb. 8.
You may also be interested in...
Budget Crunch Forces CDRH To Abbreviate Baseline Device GMP Inspections
CDRH plans to dramatically increase its inspections of domestic medical device facilities performed this year by reviewing only two of the four major QSIT subsystems in each "baseline" audit.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.