# FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - October 13, 2025

Source: https://www.keypedia.com/records/483/alps-pharmaceutical-industrial-co-ltd/c8e4a1c5-ff9c-4e07-a359-22561b15ce13

> FDA 483 for Alps Pharmaceutical Industrial Co., Ltd. on October 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alps Pharmaceutical Industrial Co., Ltd.
- Inspection Date: 2025-10-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Alps Pharmaceutical Ind. Co., Ltd. in Hida City, Japan, revealed two significant observations regarding laboratory controls. The firm failed to follow its own QC laboratory procedure for synchronizing instrument times, and its microbiological laboratory lacked written procedures for cleaning incubators and properly labeling prepared media. These deficiencies suggest inadequate control over critical laboratory processes for active pharmaceutical ingredients shipped to the US.

## Related Documents

- [483 - 2019-04-05](https://www.keypedia.com/records/483/alps-pharmaceutical-industrial-co-ltd/ef3d3312-155d-4c2b-8291-14ee3a8c18da)
- [483 - 2025-10-13](https://www.keypedia.com/records/483/alps-pharmaceutical-industrial-co-ltd/0f96d575-9687-4658-a376-5b635ee2d717)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/alps-pharmaceutical-industrial-co-ltd/b7368086-4ecc-4cbe-b942-494bb1340c79

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