FDA’s Inspectional Authority: Inviolate or On Shaky Ground?

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

Smile, You’re On FDA-Camera!

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

Welcome To The Party Compounders!

The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning FDA’s July 2014 Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section... Read more

FDA Warning Letters Increase 155% from 2010 Levels

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement activities since 2008.  Alternatively, if you are involved at all with supply chain,... Read more

CAPA – The Untold Story

Try as I might in my consulting work, I can never seem to get away from CAPA.    As much as I would like to help companies prospectively improve their process control;   embrace better quality system integration and document... Read more