FDA Inspection
Nippon Kayaku Pharmatech Co., Ltd.Nippon Kayaku Pharmatech Co., Ltd. – FDA Inspection, Sep 4, 2026
Record Details
This FDA Inspection record concerns Nippon Kayaku Pharmatech Co., Ltd., with an inspection on September 4, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 77bf1560-ef7b-4938-a61e-dbd109da0aef
Inspection Facts
- Inspection number
- 1335048
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Nippon Kayaku Pharmatech Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 25, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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