MicroBiopharm Japan Co., Ltd. – FDA 483, Feb 9, 2026

MicroBioPharm Japan Co., Ltd. in Iwata, Japan, an API manufacturer, received three observations during an FDA inspection. The firm failed to establish adequate procedures for equipment cleaning and maintenance, and did not validate cleaning procedures. Additionally, the firm lacked appropriate written procedures for equipment qualification and performed inadequate process validations using unqualified equipment.