FDA Inspection
Sepal Reproductive Devices, Inc.Sepal Reproductive Devices, Inc. – FDA Inspection, Jan 26, 2011
Record Details
This FDA Inspection record concerns Sepal Reproductive Devices, Inc., with an inspection on January 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 26, 2011
- Product Type
- Devices
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ID · 4402df87-6f94-4809-bccc-b3aab72e52ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712406
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Sepal Reproductive Devices, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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