www.fdanews.com/articles/192049-fda-raps-florida-otc-drugmaker-for-flawed-quality-system
FDA Raps Florida OTC Drugmaker for Flawed Quality System
July 18, 2019
The FDA cited Brooksville, Florida OTC drug manufacturer TG United for multiple quality violations.
In one instance, the firm used two quarantined ingredients to make liquid drug product batches, agency officials discovered during a Dec. 17, 2018–Feb. 15, 2019 inspection.
The facility also left investigations open for extended periods without documenting their status or following up.
TG United also lacked written documentation — such as a validation or qualification protocol — to show its test methods for raw ingredients, finished products and stability testing provided reliable results.
