FDA EIR - Unknown Company - June 16, 2023

An FDA inspection of TOYO Pharmaceutical Co., Ltd., a drug and contract drug manufacturer in Osaka, Japan, occurred from June 12-16, 2023. This was the firm's inaugural on-site FDA inspection, conducted under compliance program 7356.002 for Drug Manufacturing Inspections, focusing on non-sterile ointments such as Hyftor (Sirolimus) 0.2% gel. The comprehensive review assessed the company's Quality, Materials, Facilities & Equipment, Manufacturing, Packaging & Labeling, and Laboratory systems. Upon conclusion, an FDA Form 483, Inspectional Observations, was issued. Primary findings included insufficient recording and justification of deviations from written production and process control procedures. Furthermore, employees engaged in drug product packing lacked the necessary training for their roles. Other issues discussed with management involved the absence of established training requirements and an overdue training tracking system, validation of product filling processes using empty vials, and improper configuration of electronic GMP document management software access. In-process product residue was also not adequately accounted for in calculations, and temperature mapping for cold storage demonstrated inadequate frequency. TOYO Pharmaceutical Co., Ltd. management committed to providing a written response to the FDA 483 and all discussed items within 15 working days to the International Inspection Office.