# FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - August 07, 2025

Source: https://www.globalkeysolutions.net/records/483/sumitomo-dainippon-pharma-co-ltd/628e7814-ad3c-4132-bf5c-8987bf6047c2

> FDA 483 for Sumitomo Dainippon Pharma Co., Ltd. on August 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Dainippon Pharma Co., Ltd.
- Inspection Date: 2025-08-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sumitomo Pharma Co., Ltd. in Suzuka, Japan, a drug manufacturer, revealed three significant deficiencies. The firm failed to establish appropriate sampling criteria for incoming raw materials, lacked adequate procedures to prevent objectionable microorganisms in non-sterile drug products, and did not maintain complete backups of electronic data from critical visual inspection equipment. These observations indicate a need for improved quality control and data integrity practices.

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## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.globalkeysolutions.net/companies/sumitomo-dainippon-pharma-co-ltd/40ead027-5fd5-4deb-a37b-40301cffd612

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8