FDA Inspection
Remel Europe Ltd.Remel Europe Ltd. – FDA Inspection, May 31, 2013
Record Details
This FDA Inspection record concerns Remel Europe Ltd., with an inspection on May 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Remel Europe Ltd.
- Inspection Date
- May 31, 2013
- Product Type
- Devices
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ID · 4ea1fcbe-92b6-43ad-aa60-1e72cf88e8f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840261
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
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Other FDA inspections of Remel Europe Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2019 | Not classified | Office of Inspections and Investigations | |
| February 11, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Remel Europe Ltd.
- FDA Inspection 1116790 - 2019-04-04
- FDA Inspection 961738 - 2016-02-11
- FDA Inspection 580616 - 2009-04-09
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