FDA Inspection
Oishi Koseido Co., Ltd.Oishi Koseido Co., Ltd. – FDA Inspection, Sep 1, 2023
Record Details
This FDA Inspection record concerns Oishi Koseido Co., Ltd., with an inspection on September 1, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9e21866d-cca2-4a4d-aa64-3954fb5fe0ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216777
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of Oishi Koseido Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Office of Inspections and Investigations | |
| December 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Oishi Koseido Co., Ltd.
- FDA Inspection 1341740 - 2026-09-18
- FDA Inspection 1037551 - 2017-12-08
- FDA Inspection 956220 - 2016-01-29
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