Unpacking Averages: Device Inspection Citations That Frequently Precede Warning Letters
Health Law Advisor
MAY 3, 2022
In contrast to the complaint handling example, hypothetically let’s say that FDA in fiscal 2014 issued 10 citations to the effect that a correction or removal conducted to reduce a risk to health posed by device was not reported to FDA. Report of risk to health. Quality policy and objectives. Interpretation. High-Level Meaning.
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