FDA Inspection
Carolon CompanyCarolon Company – FDA Inspection, Jun 15, 2023
Record Details
This FDA Inspection record concerns Carolon Company, with an inspection on June 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · d85cd7bf-f907-4986-9651-8a1104d99d9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208125
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.18(e)Results of evaluation not in mfr's MDR file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carolon Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 8, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2012 | VAI | 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 988219 - 2016-09-21
- FDA Inspection 879287 - 2014-05-08
- FDA Inspection 797456 - 2012-08-06
- FDA Inspection 577346 - 2009-04-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.