Biopharma / Pharma

//Biopharma / Pharma

Week of September 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.

Week of August 26th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

The FDA posted 13 new warning letters this week including 7 issued by the Center for Tobacco Products, 1 to a device firm, and 1 to a compounding pharmacy. Four warning letters regarding 21 websites illegally marketing unapproved and misbranded versions of opioids including tramadol. Both the device firm and pharmacy letters are covered in this post.

The Easy Way to Research the FDA Using Keyword Search

The FDAzilla database contains information on every FDA inspected site since the year 2000. All of our 483s and warning letters -- over 25,000 documents -- are retyped, and keywords are tagged + categorized. In this video demonstration, we show you how to perform a keyword search of FDA warning letters in our system. To continue, either watch the video below or continue reading.