FDA Inspection
Carolon CompanyCarolon Company – FDA Inspection, Aug 6, 2012
Record Details
This FDA Inspection record concerns Carolon Company, with an inspection on August 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Carolon Company
- Inspection Date
- August 6, 2012
- Product Type
- Devices
View Company Profile
ID · 0997cee0-370d-4ee3-8a55-4969740c120e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 797456
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carolon Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 15, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Carolon Company
- FDA Inspection 1208125 - 2023-06-15
- FDA Inspection 988219 - 2016-09-21
- FDA Inspection 879287 - 2014-05-08
- FDA Inspection 577346 - 2009-04-15
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