# FDA 483 - Shire Human Genetic Therapies, Inc. - March 23, 2022

Source: https://www.globalkeysolutions.net/records/483/shire-human-genetic-therapies-inc/b0a0181d-afc7-4c9c-a6b0-5e0abb947400

> FDA 483 for Shire Human Genetic Therapies, Inc. on March 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shire Human Genetic Therapies, Inc.
- Inspection Date: 2022-03-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Takeda's drug substance manufacturing facility in Lexington, MA, revealed four significant observations. These included inadequate manufacturing batch records for lanadelumab, a technician's failure to follow aseptic technique during sampling, insufficient control over a laminar flow clean bench system, and unqualified compressed gas utilities lacking critical testing.

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## Related Officers

- [company_representative](https://www.globalkeysolutions.net/people/scott-lee/337531e8-7f7a-4131-9114-f4074aef421b)
- [issuing_officer](https://www.globalkeysolutions.net/people/charles-y-kuo/36d44416-c980-4b33-b62e-ea0761a46a46)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/shire-human-genetic-therapies-inc/7051823d-8cc7-4d72-8a82-a0de9bbb9497

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