FDA Inspection
Nippon Kayaku Pharmatech Co., Ltd.Nippon Kayaku Pharmatech Co., Ltd. – FDA Inspection, Nov 25, 2022
Record Details
This FDA Inspection record concerns Nippon Kayaku Pharmatech Co., Ltd., with an inspection on November 25, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 25, 2022
- Product Type
- Drugs
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ID · 7595fc4c-3ff0-4fc0-b834-27f05930500e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1192063
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Nippon Kayaku Pharmatech Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
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