FDA Inspection
Shire Human Genetic Therapies, Inc.Shire Human Genetic Therapies, Inc. – FDA Inspection, Jul 25, 2018
Record Details
This FDA Inspection record concerns Shire Human Genetic Therapies, Inc., with an inspection on July 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 48bf3ed1-b711-4574-91fe-82f89a3e920c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061705
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
Other FDA inspections of Shire Human Genetic Therapies, Inc.
20| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2025 | Not classified | New England District Office | |
| 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 | |
| January 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shire Human Genetic Therapies, Inc.
- FDA Inspection 1297340 - 2025-12-18
- FDA Inspection 1167818 - 2022-04-22
- FDA Inspection 1116968 - 2020-01-15
- FDA Inspection 1106210 - 2018-11-09
- FDA Inspection 1004081 - 2017-01-20
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