FDA 483 - YAHON ENTERPRISE CO., LTD - December 21, 2023

Yahon Enterprise Co., Ltd. in Trang Bom District, Vietnam, was cited for numerous significant deficiencies during an FDA inspection related to drug product manufacturing. The firm failed to ensure product quality and integrity through inadequate testing, lack of validation, poor record-keeping, and insufficient quality control procedures. These issues indicate a systemic failure to adhere to Good Manufacturing Practices for drug products intended for the U.S. market.