FDA Inspection
Ohta's Isan Co., Ltd.Ohta's Isan Co., Ltd. – FDA Inspection, Oct 28, 2016
Record Details
This FDA Inspection record concerns Ohta's Isan Co., Ltd., with an inspection on October 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 746e5c5a-edec-4150-afa9-6bdc16a04f4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993138
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.56(b)Written sanitation procedures lacking
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Other FDA inspections of Ohta's Isan Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ohta's Isan Co., Ltd.
- FDA Inspection 1225352 - 2023-10-27
- FDA Inspection 811423 - 2012-11-01
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