FDA EIR - Llorens Pharmaceuticals International Division, Inc. - August 20, 2019

Llorens Pharmaceuticals International Division, Inc., a manufacturer of liquid dietary supplements and OTC drugs located in Miami, FL, underwent an FDA inspection from August 20 to August 29, 2019. The inspection primarily focused on the firm's dietary supplement manufacturing and packaging operations, under the regulatory framework of 21 CFR Part 111 for dietary supplements. The main deficiency identified during this inspection, resulting in a Form FDA 483, was the company's failure to retain batch production records for the required duration, as mandated by 21 CFR 111.255(d). Specifically, master batch records for finished products Emulsion de Cod Orange Lot#M173 and Emulsion de Cod Strawberry Lot# M174, manufactured in December 2018 and with a December 2020 expiration date, were unavailable. These products had been sold and distributed. At the inspection's conclusion, the company owner was informed of the deviation and the potential for legal sanctions if voluntary corrective actions were not implemented. Management committed to addressing the issue and submitting a written response to the FDA within fifteen days. This inspection followed a previous dietary supplement inspection in 2016 which noted deficiencies regarding specifications, component testing, and record-keeping, though corrective actions for those were not verified in the current review.