# FDA 483 - MicroBiopharm Japan Co., Ltd. - February 09, 2026

Source: https://www.keypedia.com/records/483/microbiopharm-japan-co-ltd/4801bbc8-7f65-4bde-9a32-be6c47f8304d

> FDA 483 for MicroBiopharm Japan Co., Ltd. on February 09, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MicroBiopharm Japan Co., Ltd.
- Inspection Date: 2026-02-09
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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.

## Related Documents

- [483 - 2019-09-13](https://www.keypedia.com/records/483/microbiopharm-japan-co-ltd/15e359b0-2f23-43b2-b81c-518b5fa71258)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/microbiopharm-japan-co-ltd/30cd7895-86c9-46ed-bee9-e7131c700977

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3