FDA 483 - Bora Pharmaceuticals Laboratories, Inc - July 21, 2025

Bora Pharmaceuticals Laboratories, Inc. in Zhunan Township, Taiwan, received an FDA Form 483 citing multiple significant deficiencies. These included inadequate production and process controls, failure to thoroughly review unexplained discrepancies, and non-adherence to complaint handling procedures. Additionally, master production records lacked complete instructions, and the annual quality standards evaluation used a deficient sampling plan for retain samples.