FDA Inspection
The Morel Company, LLCThe Morel Company, LLC – FDA Inspection, Nov 1, 2018
Record Details
This FDA Inspection record concerns The Morel Company, LLC, with an inspection on November 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Teresa K. Kastner
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ID · a6be3cc6-9659-4ce8-bbab-5614334e806c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070564
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of The Morel Company, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2024 | 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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