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Deep Dive: First FDA Warning Letter Under QMSR
Under QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system.
FDA’s warning letter to Linemaster Switch Corporation provides an early look at QMSR enforcement in practice. The cited deficiencies extend across risk management, rework, corrective action, environmental controls, calibration, and software validation.
The individual expectations are not entirely new. What has changed is the regulatory structure through which FDA evaluates them. By citing specific ISO 13485:2016 clauses, FDA can follow the connections…
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