FDA Inspection
Kovas Co., Ltd.Kovas Co., Ltd. – FDA Inspection, Nov 22, 2019
Record Details
This FDA Inspection record concerns Kovas Co., Ltd., with an inspection on November 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kovas Co., Ltd.
- Inspection Date
- November 22, 2019
- Product Type
- Drugs
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ID · 3f95ee6d-00ed-4128-9fe2-458359e3377a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111786
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Kovas Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2024 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
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