# FDA 483 - Takeda Manufacturing Italia SPA - November 15, 2019

Source: https://www.keypedia.com/records/483/takeda-manufacturing-italia-spa/54cd2ab3-3bed-4e90-ae1a-68513f3fbeb6

> FDA 483 for Takeda Manufacturing Italia SPA on November 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Manufacturing Italia SPA
- Inspection Date: 2019-11-15
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Baxter Manufacturing S.p.A. in Rieti, Italy, was inspected and cited for multiple deficiencies related to manufacturing controls, quality systems, and documentation practices. Observations include inadequate cleaning validation documentation, failure to follow procedures, deficient verification checks, incomplete investigations, and insufficient stability studies for temperature excursions. These issues indicate significant concerns regarding product quality and data integrity.

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## Related Officers

- [Ana Marcial](https://www.keypedia.com/people/ana-marcial/91c66cdc-4baa-451b-9d47-ac9602138f72)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/takeda-manufacturing-italia-spa/1998fa46-5f10-426b-b959-5378f2b887e1

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd