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.
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.
In the past 2 weeks, we added the following 74 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
Govzilla is on the road again! We hope to see you at the 27th Annual PDA/FDA Joint Regulatory Conference in Washington, DC from September 24th-26th. Here is the full list of speakers and events happening at the conference (including the one we wouldn’t miss).
“As FDAzilla continues to grow, we believe we must do our part - locally and globally - to do good by doing well.” Tony Chen (one of our co-founders) shares this unique story of who we really are at FDAzilla.
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 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.
An efficient summary of all things FDA/GMP related for the entire month of August 2018. Warning letters, a refusal of an FDA inspection, new guidance, etc. See the complete run down here.
In the past 2 weeks, we added the following 93 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.