FDA Inspection
Remel, IncRemel, Inc – FDA Inspection, Jun 25, 2013
Record Details
This FDA Inspection record concerns Remel, Inc, with an inspection on June 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Remel, Inc
- Inspection Date
- June 25, 2013
- Product Type
- Devices
View Company Profile
ID · c54b0fbe-4d6d-492d-8bba-515eb1f484a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836927
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
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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 |
| October 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 3, 2014 | VAI | Center for Devices and Radiological Health | Compliance: 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 953769 - 2015-10-23
- FDA Inspection 885210 - 2014-07-03
- FDA Inspection 823206 - 2013-03-07
- FDA Inspection 658081 - 2010-03-18
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