FDA Inspection
Shire Human Genetic Therapies, Inc.Shire Human Genetic Therapies, Inc. – FDA Inspection, Dec 18, 2025
Record Details
This FDA Inspection record concerns Shire Human Genetic Therapies, Inc., with an inspection on December 18, 2025, issued by the New England District Office, covering human drugs.
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ID · b66e1add-a72b-454b-ae49-945906abc3d0
Inspection Facts
- Inspection number
- 1297340
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
Other FDA inspections of Shire Human Genetic Therapies, Inc.
20| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | Not classified | New England District Office | |
| July 25, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shire Human Genetic Therapies, Inc.
- FDA Inspection 1167818 - 2022-04-22
- FDA Inspection 1116968 - 2020-01-15
- FDA Inspection 1106210 - 2018-11-09
- FDA Inspection 1061705 - 2018-07-25
- FDA Inspection 1004081 - 2017-01-20
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