FDA Inspection
Kovas Co., Ltd.Kovas Co., Ltd. – FDA Inspection, Nov 29, 2024
Record Details
This FDA Inspection record concerns Kovas Co., Ltd., with an inspection on November 29, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 6c54c2a8-2349-4b86-9a96-af4565c9453a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255462
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Kovas Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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