FDA Inspection
Shionogi Inc.Shionogi Inc. – FDA Inspection, Feb 2, 2015
Record Details
This FDA Inspection record concerns Shionogi Inc., with an inspection on February 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Shionogi Inc.
- Inspection Date
- February 2, 2015
- Product Type
- Drugs
View Company Profile
ID · 1a868783-9a61-4b83-8b59-de8027c0851c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912412
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| 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 |
| July 9, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shionogi Inc.
- FDA Inspection 1044405 - 2018-02-15
- FDA Inspection 832707 - 2013-05-16
- FDA Inspection 766562 - 2012-02-08
- FDA Inspection 681164 - 2010-07-09
- FDA Inspection 674381 - 2010-07-09
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