# FDA 483 - Takeda - September 25, 2019

Source: https://www.keypedia.com/records/483/takeda/24d6b334-0b96-4884-8662-276eba08e27b

> FDA 483 for Takeda on September 25, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda
- Inspection Date: 2019-09-25
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Takeda's biologic drug manufacturing facility in Round Lake, IL, revealed significant deficiencies. The firm was cited for failing to minimize contamination risk during albumin bulk filling operations, evidenced by microbial exceedances. Additionally, Takeda's corrective actions were deemed ineffective in addressing recurring issues with leaking product bags, and the company failed to complete its required annual drug establishment registration.

## Related Officers

- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/takeda/44e44237-b126-4795-9115-20e02ec5e987

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669