FDA Inspection
Carol Cole Company, Inc.Carol Cole Company, Inc. – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns Carol Cole Company, Inc., with an inspection on March 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5e721a7c-21fb-4b8c-aa29-1cd5f8421a90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083562
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Carol Cole Company, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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