FDA 483 - Bora Pharmaceuticals (frmly: TWI Pharmaceuticals, Inc.) - March 27, 2026

Bora Pharmaceutical Laboratories Inc. Zhongli Plant in Taoyuan City, Taiwan, was cited for significant deficiencies in its drug manufacturing operations. The inspection revealed critical issues including inadequate cleaning validation, repeated failures to investigate out-of-specification results and foreign matter, and insufficient controls over computerized systems. Additionally, the firm demonstrated poor management of manufacturing materials, indicating a systemic lack of quality control.