FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Jul 22, 2016
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on July 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 22, 2016
- Product Type
- Drugs
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ID · a62a1e23-6960-4512-ada8-acd3227fda58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully 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 | |
| February 15, 2019 | 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 1079491 - 2019-02-15
- FDA Inspection 873409 - 2014-03-20
- FDA Inspection 754803 - 2011-10-21
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