FDA 483 - Tropichem Research Labs, LLC dba Vetio - December 14, 2018

ProfiChem Research Labs, LLC dba Vetio Animal Health in Jupiter, FL, a drug manufacturer, received a Form 483 with seven observations during an inspection from December 10-14, 2018. The inspection revealed significant deficiencies in quality control, including failures to investigate out-of-specification results, inadequate finished product testing, poor computer system controls, and lack of equipment qualification, process validation, and stability data for animal drug products. Several observations were repeats from a previous inspection, indicating persistent issues.