FDA Enforcement Trends

Week of November 11th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

This week the FDA posted 4 new warning letters. One was issued to a cell/tissue product manufacturer, 1 to a firm for failure to list, 1 to a compounding pharmacy, and 1 to a device manufacturer. We cover 3 of these in this post.

Week of October 21st 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 10 warning letters this week: 8 of them citing unapproved or misbranded new drugs with problematic websites as the source of FDA’s information. Along with this, 1 warning letter was published that was issued to a compounding pharmacy.