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”
Through the release of Form 483, it has become clear that the FDA identified multiple "observations" at Triad Group Headquarters in Hartland, Wisconsin. Specifically, 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, jelly, and numerous IV prep antiseptic wipes.
The FDA visited the site twenty times over a three month span starting on November 29, 2010 and ending on January 7, 2011. Over that course of time the FDA noted multiple concerns. The "Medical Devices – Sterile Lube Jelly" (observations 1 through 6), the "Facilities and Equipment" (observations 37 through 41) and the "Packaging and Labeling System" (observation 46), all came up short. In fact, from the outset of the report, it is evident that proper procedures were not being followed. The very first observation in Form 483 states: "Procedures for corrective and preventative action have not been established."
Clearly, the FDA knew problems existed with the Triad Group. The focus should now be – what can we do to correct Triad’s problems in light of the FDA’s observations.