FDA 483 - Tuscano and Delucia Group DBA Entropic Labs - September 26, 2019
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An FDA inspection of Tuscano and Delucia Group (DBA Entropic Labs) in Salt Lake City, UT, revealed severe deficiencies across its pharmaceutical and dietary supplement operations. The firm lacked fundamental quality control units, written procedures for complaint handling, master production records, laboratory controls, and stability testing programs. These widespread issues indicate a critical failure to adhere to good manufacturing practices, posing potential risks to product quality and consumer safety.
- Inspection Date
- September 26, 2019
- Product Type
- Drugs
ID · cb528d5b-241e-45fe-93b4-c8ffa5594787