Triad Group Hartland, WI Form FDA-483 Inspection Dates 11/29/2010 - 1/7/2011 Comment Enclosed are comments from a total of seven observations representing various Systems to include Laboratory Control, Production, and Material obtained as a subset from the forty six observations within Triad Group's recent FDA 483 which resulted in a recall of their alcohol prep pads, … [Read more...]
USP BACTERIAL ENDOTOXIN TEST
The USP has announced that USP<85> will become effective in April 2011. … [Read more...]
Barry A Friedman, PhD LLC
Barry A Friedman, PhD LLC PURPOSE AND SCOPE The purpose of this Web Site is to share with the FDA regulated community recent activities within the FDA and the USP that you may find of interest. This will include, in particular, Warning Letters and their application to your various activities. It will also focus upon new drafts of Guidance for Industry … [Read more...]
