Florida Drugmaker Warned for Repeat Violations

The FDA hit TG United’s drug manufacturing facility north of Tampa, Florida with a warning letter for repeat water system and cleaning failures found during a lengthy inspection.

The agency inspected the Brooksville facility from Dec. 17, 2018 to Feb. 15, 2019 and cited the  firm for investigations of out-of-specification results and water system monitoring failures.

The facility continued manufacturing operations while multiple investigations stability, finished product and raw material testing results were incomplete — a repeat violation from a 2017 agency inspection.