FDA Inspection
Remel Cleveland, a Division of Remel Inc.FDA Inspection 1259798 - Remel Cleveland, a Division of Remel Inc. - February 03, 2025
Record Details
This FDA Inspection record concerns Remel Cleveland, a Division of Remel Inc., with an inspection on February 3, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93e3bd94-67bd-4360-bb99-43d8370922ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259798
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Remel Cleveland, a Division of Remel Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 16, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Remel Cleveland, a Division of Remel Inc.
- FDA Inspection 1110500 - 2019-11-20
- FDA Inspection 1009751 - 2017-04-12
- FDA Inspection 652081 - 2010-03-16
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