# FDA 483 - Takeda Pharmaceuticals U.S.A., Inc. - March 18, 2020

Source: https://www.globalkeysolutions.net/records/483/takeda-pharmaceuticals-usa-inc/ff4aed4d-be39-4f7b-a6f3-55f18ecaa986

> FDA 483 for Takeda Pharmaceuticals U.S.A., Inc. on March 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceuticals U.S.A., Inc.
- Inspection Date: 2020-03-18
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Takeda Pharmaceuticals U.S.A., Inc. in Brooklyn Park, MN, a drug substance manufacturer, was issued a Form 483 with three observations. The inspection revealed inadequate cleaning validation for manufacturing equipment, insufficient quality oversight for outsourced qualification studies, and deficiencies in Standard Operating Procedures. These issues indicate potential risks to product quality and control.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/takeda-pharmaceuticals-usa-inc/973c4fb1-7870-473f-8565-9e4e6b2f61ff)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/takeda-pharmaceuticals-usa-inc/fdcf90e5-4395-4923-ac61-dd2fb0337b48)

## Related Officers

- [Eric Hales](https://www.globalkeysolutions.net/people/eric-hales/5fa2221a-8773-4466-b504-14948db995be)
- [Kristen Nickens](https://www.globalkeysolutions.net/people/kristen-nickens/d68c87e1-e14c-48f7-86e9-686a3870c777)
- [Scott A. Golladay](https://www.globalkeysolutions.net/people/scott-a-golladay/78c90066-7212-4442-900c-5cdcb677aeec)

Company: https://www.globalkeysolutions.net/companies/takeda-pharmaceuticals-usa-inc/ac41523a-6533-41f1-b63e-c5b5d9a5a2bf

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd