FDA Inspection
Kaken Pharmaceutical Co., Ltd.Kaken Pharmaceutical Co., Ltd. – FDA Inspection, Jun 22, 2018
Record Details
This FDA Inspection record concerns Kaken Pharmaceutical Co., Ltd., with an inspection on June 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 15291c56-7260-4bae-96a7-86f32476adaa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056547
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Kaken Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 14, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kaken Pharmaceutical Co., Ltd.
- FDA Inspection 1219421 - 2023-09-01
- FDA Inspection 873743 - 2014-03-28
- FDA Inspection 813922 - 2012-11-14
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