# FDA 483 - Shire Human Genetic Therapies, Inc. - April 22, 2022

Source: https://www.globalkeysolutions.net/records/483/shire-human-genetic-therapies-inc/91b0c891-d7c9-41c4-856e-464b842ee491

> FDA 483 for Shire Human Genetic Therapies, Inc. on April 22, 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: 2022-04-22
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Shire Human Genetic Therapies, Inc. in Lexington, MA, an Active Pharmaceutical Ingredient Manufacturer, received a Form 483 for a critical lapse in its Quality unit's oversight. The firm failed to adequately assess the impact of chromatography systems that had not undergone routine calibration since 2014 on the analytical testing of Velaglucerase Alfa and Idursulfase drug substances and products. This indicates a significant control deficiency that could impact product quality.

## Related Documents

- [483 - 2022-03-23](https://www.globalkeysolutions.net/records/483/shire-human-genetic-therapies-inc/b0a0181d-afc7-4c9c-a6b0-5e0abb947400)
- [483 - 2022-04-22](https://www.globalkeysolutions.net/records/483/shire-human-genetic-therapies-inc/43f8e360-2187-4f47-8b0a-0a87875029db)
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## Related Officers

- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7