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FDA Inspection
•Shire Human Genetic Therapies, Inc.•May 23, 2013

Shire Human Genetic Therapies, Inc. – FDA Inspection, May 23, 2013

Record Details

This FDA Inspection record concerns Shire Human Genetic Therapies, Inc., with an inspection on May 23, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Shire Human Genetic Therapies, Inc.
Inspection Date
May 23, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6967c0ce-dcfa-42cd-bb40-b91a2562b2a1

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
833938
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of Shire Human Genetic Therapies, Inc.

20
DateClassificationOfficeProject area
December 18, 2025Not classifiedNew England District Office
April 22, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 15, 2020NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 9, 2018Not classifiedNew England District Office
July 25, 2018VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 20 other inspections on the company page
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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Contact
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