FDA 483 - Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant, Research Building - November 04, 2022

Synpac-Kingdom Pharmaceutical Company Ltd in Taoyuan City, Taiwan, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, inadequate validation of aseptic processes for sterile drug products, and a failure to thoroughly investigate unexplained discrepancies and out-of-specification results. These issues indicate a lack of robust quality control and assurance for drug product identity, strength, quality, and purity.