FDA EIR - Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant, Research Building - November 04, 2022

An FDA Pre-Approval Inspection (PAI) was conducted at Synpac-Kingdom Pharmaceutical Co., Ltd.'s Taoyuan plant in Taiwan from October 27 to November 4, 2022. This marked the facility's first U.S. FDA inspection, aimed at assessing its capability as a manufacturer of sterile human prescription drug products for potential U.S. market entry. The inspection thoroughly covered critical areas including quality, production, materials, facilities, equipment, packaging, labeling, and laboratory controls, adhering to the regulatory framework for pre-approval inspections of sterile drug products.The inspection resulted in three significant observations documented on an FDA-483. Key issues identified included the absence of written procedures for production and process controls essential to ensure drug product identity, strength, quality, and purity. Additionally, the firm lacked adequate validation of its aseptic process, which is vital for preventing microbiological contamination in sterile products. A third observation noted a failure to thoroughly investigate unexplained manufacturing discrepancies. The company's Site General Manager, Mr. Tom Chang, acknowledged the findings and committed to submitting a written response within 15 working days. The FDA will review this response before making any final regulatory decisions. Despite the observations, the inspection concluded with a "Voluntary Action Indicated" (VAI) classification, recommending an "Acceptable" status for the firm's role as a manufacturer for the specific drug products under review for U.S. market approval.