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

Source: https://www.keypedia.com/records/483/takeda-manufacturing-italia-spa/79cbe83a-3add-484f-bc65-516a9d3c768a

> 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
- Summary: Between November 4 and November 12, 2024, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Takeda Manufacturing Italia SPA plasma manufacturing facility located in Cittaducale, Rieti, Italy. The inspection resulted in the issuance of Form 483, which details several areas of non-compliance with quality and safety standards. Key violations identified include incomplete batch production records that failed to document the specific major equipment used during critical manufacturing stages, such as centrifugation. Additionally, the facility did not consistently follow its own internal protocols for investigating production deviations; specifically, the firm failed to identify root causes when intermediate plasma batches tested positive for Parvovirus B19. Investigators also noted deficiencies in equipment sanitation and maintenance, highlighting a lack of traceability for individual utensils and the absence of established usage cycles or expiration limits for tools used in the manufacturing process. These observations were issued under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. Although these findings do not constitute a final agency determination, Takeda is required to respond to the FDA with a detailed corrective action plan or submit objections regarding the findings to ensure ongoing compliance with federal regulations.

## 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/18b6e9a8-1cd3-4416-b558-2eb268ec327a)

## 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