SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.  One of the problem areas most often cited in company audits continue to be the CAPA system/program.  This month we will take a look at some of the latest FDA...
Medical Device Engineering
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
A Review of FDA 483 Observations – Top Med Device Issues Sited & Proper Response
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.