# FDA 483 - Takeda Pharmaceutical Company Limited - August 09, 2019

Source: https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/72674c7d-eac6-46c5-9170-4559dbfbe47b

> FDA 483 for Takeda Pharmaceutical Company Limited on August 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2019-08-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Takeda Pharmaceutical Company Limited in Osaka, Japan, received a Form FDA 483 with four observations following an inspection from August 1-9, 2019. The firm was cited for inadequate aseptic process validation, insufficient laboratory controls for sterility assurance, incomplete laboratory records for process simulation tests, and unjustified deviations from production procedures. These issues collectively indicate deficiencies in ensuring the quality and purity of sterile drug products.

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## Related Officers

- [Sam J Zamil](https://www.globalkeysolutions.net/people/sam-j-zamil/8199d01c-86c7-47a3-851b-3c5c40159e8c)
- [Patric C. Klotzbuecher](https://www.globalkeysolutions.net/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

Company: https://www.globalkeysolutions.net/companies/takeda-pharmaceutical-company-limited/185c125c-128f-47be-ab1b-e1d5324bcc21

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