The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and compliance staff on “How to Manage an FDA Inspection”. Regularly, FDA inspection management... Read more
I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder (from his firm's excellent FDALawBlog) surrounding FDA's inspectional authority and whether that authority is "evolving" due to recent Supreme Court decisions. Please... Read more
The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more
