# FDA 483 - Takeda Pharmaceutical Company Limited - November 01, 2023

Source: https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/1896dda4-c7e8-4da9-b91a-daba1da128bc

> FDA 483 for Takeda Pharmaceutical Company Limited on November 01, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2023-11-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Takeda Pharmaceutical Company Limited in Hikari, Japan, was cited with a Form FDA 483 for multiple quality control deficiencies during an inspection. Observations included a lack of comprehensive investigations into critical quality complaints for Lupron Depot, insufficient review of product discrepancies, and inadequate environmental monitoring in aseptic processing areas. Additionally, the firm failed to perform appropriate laboratory testing for objectionable microorganisms on drug product batches.

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## Related Officers

- [David J. Gomes](https://www.globalkeysolutions.net/people/david-j-gomes/dc3d1557-3bbc-4ed6-85fc-84b3462715c1)
- [Investigator](https://www.globalkeysolutions.net/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.globalkeysolutions.net/companies/takeda-pharmaceutical-company-limited/0f6bd1ca-94a2-41f0-a8dd-1af20069e6cf

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1