On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective ...
MDLN faces FDA warning over cGMP lapses in angiographic syringes, citing weak quality controls, CAPA gaps and design flaws despite escalating share price.
The FDA Recalls Masterclass offers key learning for professionals to enhance recall preparation, compliance, and risk management strategies, minimizing financial impacts and corporate image damage ...
A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one ...
The U.S. Food and Drug Administration (FDA) published a draft guidance—the first of its kind—consolidating its expectations for how drug manufacturers should respond to Form 483 inspectional ...
Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...
The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design ...
The U.S. FDA’s inspection of two facilities run by San Francisco-based Irhythm Technologies Inc., illuminated some of the usual problems with corrective and preventive action. The agency indicated ...
Medline Inc. (MDLN recently received a warning letter from the FDA, citing multiple violations related to manufacturing and quality system processes at its New York facility. The regulatory action ...
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