A key role that the FDA performs is gate-keeping defective, or worse, dangerous products from being dispensed to the general public. As part of this duty, the FDA will conduct inspections under the Federal Food, Drug, and Cosmetic Act, SEC. 704 (21 USC § 374) , more commonly referred to as a “Factory Inspection”. Form 483,“Inspectional Observations,” is a form used by the FDA to identify and address concerns discovered during these inspections. Form 483’s mission is stated as follows:
“…lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”
We have learned, through the release of Form 483, that the FDA noted 46 instances of Good Manufacturing (GMP) noncompliance when they visited Triad Group headquarters in Hartland, Wisconsin.
46 instances of GMP noncompliance is rare. According toTony Chen, CEO at FDAzilla.com, the average number of observations in a Form 483 inspection report is 6. It is clear that Triad Group had a culture of problems as they packaged and prepared their alcohol wipes, pads, swabs and jelly.