# FDA 483 - Takeda Manufacturing Italia SPA - November 12, 2024

Source: https://www.keypedia.com/records/483/takeda-manufacturing-italia-spa/18b6e9a8-1cd3-4416-b558-2eb268ec327a

> FDA 483 for Takeda Manufacturing Italia SPA on November 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Manufacturing Italia SPA
- Inspection Date: 2024-11-12
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Takeda Manufacturing Italia SPA in Cittaducale, Italy, underwent an FDA inspection from November 4-12, 2024, focusing on plasma manufacturing. The inspection revealed significant deficiencies related to batch production records, adherence to written procedures, and inadequate cleaning and maintenance of equipment. These issues indicate a moderate level of non-compliance with good manufacturing practices.

## Related Documents

- [483 - 2019-11-15](https://www.keypedia.com/records/483/takeda-manufacturing-italia-spa/54cd2ab3-3bed-4e90-ae1a-68513f3fbeb6)
- [483 - 2024-11-12](https://www.keypedia.com/records/483/takeda-manufacturing-italia-spa/79cbe83a-3add-484f-bc65-516a9d3c768a)

## Related Officers

- [Alan L. Truong](https://www.keypedia.com/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

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

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