FDA Inspection
The Morel Company, LLCThe Morel Company, LLC – FDA Inspection, Jul 2, 2024
Record Details
This FDA Inspection record concerns The Morel Company, LLC, with an inspection on July 2, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 96d81625-112b-4d93-82da-ec3e5ceeef3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242930
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of The Morel Company, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 27, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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