# FDA 483 - Daiichi Sankyo Europe GmbH - July 18, 2025

Source: https://www.keypedia.com/records/483/daiichi-sankyo-europe-gmbh/5f48dc36-8c0c-4493-a634-ec2288eadad6

> FDA 483 for Daiichi Sankyo Europe GmbH on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daiichi Sankyo Europe GmbH
- Inspection Date: 2025-07-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: This FDA Form 483 was issued to Daiichi Sankyo Europe GmbH, a drug product manufacturer in Pfaffenhofen A.D. Ilm, Germany, following an inspection from July 14-18, 2025. The inspection revealed significant deficiencies in laboratory record-keeping, inadequate investigations into deviations and out-of-specification results, and failures in equipment cleaning and maintenance procedures. These observations indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)

Company: https://www.keypedia.com/companies/daiichi-sankyo-europe-gmbh/772636a4-cbb8-47ae-8aa1-fdc45ab325f6

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