FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Feb 15, 2019
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on February 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a4098463-2e7c-43b8-8bbf-1fef60d024dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079491
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Otsuka Pharmaceutical Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2025 | Not classified | Office of Inspections and Investigations | |
| July 22, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 20, 2014 | 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 980250 - 2016-07-22
- FDA Inspection 873409 - 2014-03-20
- FDA Inspection 754803 - 2011-10-21
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