Simply stated, an inspection needs to add some value; otherwise, what’s the point?
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
Trust, but verify, your suppliers.
In just about any industry, this is a basic part of a quality system.
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.
A monumental screw up, complete with bad quality, regulatory and statutory practices.
Few things motivate FDA faster than a significant number of adverse events, especially deaths.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
The latest cybersecurity threat reveals how an insulin pump is vulnerable to hackers.
Charlie Chi, former CEO of OtisMed Corp, is sentenced to prison for shipping adulterated medical devices into interstate commerce.