FDA Inspection
Shire Human Genetic Therapies, Inc.Shire Human Genetic Therapies, Inc. – FDA Inspection, Jul 15, 2015
Record Details
This FDA Inspection record concerns Shire Human Genetic Therapies, Inc., with an inspection on July 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 15, 2015
- Product Type
- Drugs
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ID · 56029fd9-287f-42c6-9c37-df7773bc659f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939368
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 | |
| July 25, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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 1061705 - 2018-07-25
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