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FDA Inspection
•Shionogi Inc.•November 5, 2012

Shionogi Inc. – FDA Inspection, Nov 5, 2012

Record Details

This FDA Inspection record concerns Shionogi Inc., with an inspection on November 5, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Shionogi Inc.
Inspection Date
November 5, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4133cce8-cb8f-45cc-87a5-99fc5c6faf1c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
807882
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 312.57(a)Records of receipt, shipment, disposition
  2. 21 CFR 312.52(a)Transfer of obligations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Shionogi Inc.

6
DateClassificationOfficeProject area
February 13, 2026Not classifiedNew Jersey District Office
December 19, 2019NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
March 12, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
October 7, 2016NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
November 17, 2015NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 6 other inspections on the company page
Other documents for Shionogi Inc.
  • FDA Inspection 1305578 - 2026-02-13
  • FDA Inspection 1115062 - 2019-12-19
  • FDA Inspection 1047601 - 2018-03-12
  • FDA Inspection 992012 - 2016-10-07
  • FDA Inspection 948537 - 2015-11-17

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