FDA Inspection
Shionogi Inc.Shionogi Inc. – FDA Inspection, Jul 9, 2010
Record Details
This FDA Inspection record concerns Shionogi Inc., with an inspection on July 9, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shionogi Inc.
- Inspection Date
- July 9, 2010
- Product Type
- Drugs
View Company Profile
ID · 85c4f041-b148-4fb1-b290-8892f7536488
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674381
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shionogi Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shionogi Inc.
- FDA Inspection 1044405 - 2018-02-15
- FDA Inspection 912412 - 2015-02-02
- FDA Inspection 832707 - 2013-05-16
- FDA Inspection 766562 - 2012-02-08
- FDA Inspection 681164 - 2010-07-09
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