FDA Inspection
Otsuka Pharmaceutical Co. Ltd.Otsuka Pharmaceutical Co. Ltd. – FDA Inspection, Aug 2, 2012
Record Details
This FDA Inspection record concerns Otsuka Pharmaceutical Co. Ltd., with an inspection on August 2, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 2, 2012
- Product Type
- Drugs
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ID · df3e3191-7a3b-4f0c-bab8-8608946d902f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796785
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Otsuka Pharmaceutical Co. Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 10, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Otsuka Pharmaceutical Co. Ltd.
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- FDA Inspection 1112200 - 2019-10-10
- FDA Inspection 1037241 - 2017-12-08
- FDA Inspection 969641 - 2016-04-15
- FDA Inspection 899637 - 2014-09-18
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