# FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - May 26, 2023

Source: https://www.keypedia.com/records/483/alps-pharmaceutical-industrial-co-ltd/1b59829d-c79f-4e56-afa9-dfea63eb6153

> FDA 483 for Alps Pharmaceutical Industrial Co., Ltd. on May 26, 2023. 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: 2023-05-26
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Alps Pharmaceutical Industrial Co. Ltd. in Hida, Gifu, Japan, an Active Pharmaceutical Ingredient (API) Manufacturer, revealed significant deficiencies. The firm failed to validate its cGMP-related software system, lacked controls for authentic personnel signatures on cGMP documents, and did not verify analytical methods for finished product testing after instrument changes.

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## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/alps-pharmaceutical-industrial-co-ltd/d68f79f1-c4d0-4161-93c1-5f9a0cbd6d05

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c