FDA Enforcement Trends

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.

Week of September 30th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 warning letters this week. A collection were from the Center for Tobacco Products. There was 1 warning letter issued to a PET firm, 1 to a device firm, and 1 to a compounding pharmacy. We cover all 3 in this post.

Week of September 16th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA published a total of 12 warning letters this week including: 2 to compounding pharmacies, 1 to an API manufacturer, 2 to finished drug manufacturers, and 1 to a device manufacturer. This post highlights key violations and includes links to all warning letters.

Posted FDA 483 Violations | Week of 9/16/18

It's 483 study time, and our GMP expert has extracted the key points in this week's featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment.