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.
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If you or someone you love was hurt as a result of a Triad product or dangerous product, please feel free to contact us to discuss your options.
Other Triad News
The FDA has permanently shut down two Wisconsin drug companies linked to contaminated medical products and repeated violations of federal safety standards, following multiple recalls and a child’s death.
The FDA seized $6 million in Triad Group products amid allegations of unsanitary manufacturing practices and shut down production.
The FDA shut down Triad Group’s drug production after contamination concerns and a child’s death linked to its products sparked lawsuits and a nationwide recall of alcohol wipes and swabs.
Patients using Copaxone for MS may face harmful side effects linked to contaminated Triad alcohol prep pads. Learn how legal action may help if you've been affected.
Contaminated Triad alcohol wipes have been linked to serious infections and a child’s death, prompting lawsuits and FDA scrutiny. Learn your legal options if you’ve been affected.
