FDA Inspection
Carwild CorporationCarwild Corporation – FDA Inspection, May 16, 2019
Record Details
This FDA Inspection record concerns Carwild Corporation, with an inspection on May 16, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8033ecad-4955-4fa1-bfea-24f4a602d121
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089736
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
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Other FDA inspections of Carwild Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 3, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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