FDA Inspection Preparation, Supply Risk Management, FDA Guidance, and More…
We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter. Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]
Today I’d like to show you how to do [...]
Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S [...]
It’s easier than you think! Let’s... Start with a [...]
Laws, Regulations, Guidance, and Concept Papers A busy week [...]
Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...
In the past 2 weeks we added the following [...]