FDA Inspection
Otsuka Pharmaceutical Co., Ltd.Otsuka Pharmaceutical Co., Ltd. – FDA Inspection, Oct 21, 2011
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co., Ltd., with an inspection on October 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 21, 2011
- Product Type
- Drugs
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ID · 7fe9353a-ab23-442a-937f-91e020ee1d55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754803
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 |
| 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 |
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 873409 - 2014-03-20
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