FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Mar 20, 2014
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on March 20, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 20, 2014
- Product Type
- Drugs
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ID · ca088a4b-f31b-4c5d-8082-143d41aeb868
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873409
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.86Rotation of components/containers/closures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Otsuka Pharmaceutical Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2025 | Not classified | Office of Inspections and Investigations | |
| February 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Otsuka Pharmaceutical Co., Ltd.
- FDA Inspection 1291346 - 2025-10-10
- FDA Inspection 1079491 - 2019-02-15
- FDA Inspection 980250 - 2016-07-22
- FDA Inspection 754803 - 2011-10-21
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