FDA Inspection
The Morel Company, LLCThe Morel Company, LLC – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns The Morel Company, LLC, with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Morel Company, LLC
- Inspection Date
- August 27, 2015
- Product Type
- Devices
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ID · 5d96fe83-def3-4333-89d0-3057d8bc9a1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939517
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR 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 |
| November 1, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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