Posts tagged Inspection Citation.
Blogs
17 minute read
Overview
In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. In this exercise, I do not try to prove causation. I am simply exploring correlation. But with that caveat in mind, I think it’s still informative to see what types of inspectional citations, in a high percentage of cases, will precede a warning letter. And, as I’ve said before, joining two different data sets – in this case inspectional data with warning letter data – might just reveal new insights.
Blog Editors
Recent Updates
- Legislative Push for FDA Preemptive Authority Over Dietary Supplement Regulation
- GUARD and GLOBE Pricing Models Could Test Manufacturer Rebates for Medicare Part B and D Drugs
- FDA’s Office of Dietary Supplement Programs Signals Key Enforcement and Policy Priorities for the Year Ahead
- OIG Issues Guidance, Request for Information on DTC Programs
- OIG Greenlights Cost-Sharing Waiver for Commercially Insured Patients