# FDA 483 - Takeda Pharmaceutical Company Limited - September 14, 2010

Source: https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/d370e845-b9ad-4d8a-bb80-a7eab12a8388

> FDA 483 for Takeda Pharmaceutical Company Limited on September 14, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2010-09-14
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Takeda Pharmaceutical Company Limited in Osaka, Japan, identified critical deficiencies in procedures for preventing microbiological contamination of sterile drug products. These issues included the use of uncalibrated equipment during annual qualifications and an employee failing to sanitize hands before performing aseptic manufacturing tasks. Additionally, the firm's aseptic processing areas were found to have an inadequate system for monitoring environmental conditions, particularly concerning personnel and pass box monitoring.

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## Related Officers

- [Parul M. Patel, Microbiologist](https://www.globalkeysolutions.net/people/parul-m-patel-microbiologist/5f7268ca-e647-4fdc-adac-76be1009ee5e)
- [Dell S. Moller, Investigator](https://www.globalkeysolutions.net/people/dell-s-moller-investigator/c4ee7074-667e-4a0e-babb-9851d0053602)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552