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

Source: https://www.keypedia.com/records/483/sumitomo-dainippon-pharma-co-ltd/86bec48e-adb4-4655-bc52-1a8046463dde

> 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 Compliance and Biologics Quality
- Summary: An FDA inspection was conducted at Suzuka Plant from August 3 to August 7, 2025, revealing several observations documented in an FDA Form 483. These observations indicate deficiencies in the firm's adherence to Good Manufacturing Practices for drug products, necessitating prompt corrective actions.

Key issues identified include inadequate sampling procedures for incoming raw materials and excipients. The firm consistently sampled only four containers per lot, regardless of the total quantity received, without documented scientific justification, compromising the representativeness of samples.

Additionally, the inspection noted a failure to establish and follow procedures for preventing objectionable microorganisms in non-sterile drug products. A critical system, utilized in drug product manufacturing and equipment cleaning, lacked evaluation for microbial absence, and no documented microbial risk assessment was performed to ensure an adequate control strategy.

Furthermore, the firm failed to maintain complete backup files for electronic data. A visual inspection instrument, crucial for detecting tablet defects, was not configured to save or transfer electronic data to retrievable storage, hindering subsequent review, verification, or audit processes.

These observations highlight critical areas where the firm must implement comprehensive corrective and preventive measures to ensure product quality, safety, and regulatory compliance.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-compliance-and-biologics-quality/5592f0a1-da8d-4887-bad6-2f16ea7451a0