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.
- NJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders
- Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities
- CMS Announces Comprehensive Plan to Ensure EMTALA Compliance
- Telehealth’s Roadblock: The Issue with State Licensure Requirements
- CMS Announces New Primary and Behavioral Health Care Integration Demonstration Model