FDA 483 - Llorens Pharmaceuticals International Division, Inc. - August 29, 2019

Llorens Pharmaceuticals International Division, Inc. in Miami, FL, a dietary supplement manufacturer, was cited for a significant record-keeping violation. The firm failed to maintain batch production records for dietary supplements for the required time period. Specifically, master batch records were not available for Emulsion de Cod Orange Lot#M173 and Emulsion de Cod Strawberry Lot# M174, despite these products having an expiration date in December 2020.