FDA Inspection
Sumika Chemical Analysis Service, Ltd.Sumika Chemical Analysis Service, Ltd. – FDA Inspection, Nov 13, 2019
Record Details
This FDA Inspection record concerns Sumika Chemical Analysis Service, Ltd., with an inspection on November 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 13, 2019
- Product Type
- Drugs
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ID · b3697a92-ba7f-4916-bd7e-cc559cce1d52
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109519
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of Sumika Chemical Analysis Service, Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 7, 2025 | Not classified | Office of Inspections and Investigations | |
| June 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sumika Chemical Analysis Service, Ltd.
- FDA Inspection 1295706 - 2025-11-07
- FDA Inspection 1060052 - 2018-06-22
- FDA Inspection 899691 - 2014-09-12
- FDA Inspection 790523 - 2012-02-24
- FDA Inspection 676820 - 2010-07-30
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