FDA Inspection
Remel, IncRemel, Inc – FDA Inspection, Oct 23, 2015
Record Details
This FDA Inspection record concerns Remel, Inc, with an inspection on October 23, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Remel, Inc
- Inspection Date
- October 23, 2015
- Product Type
- Devices
View Company Profile
ID · cbd34b65-40d7-4b42-ba0b-9de05b2f11af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953769
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Remel, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 7, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 18, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Remel, Inc
- FDA Inspection 1199839 - 2023-03-03
- FDA Inspection 885210 - 2014-07-03
- FDA Inspection 836927 - 2013-06-25
- FDA Inspection 823206 - 2013-03-07
- FDA Inspection 658081 - 2010-03-18
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