FDA Inspection
ReliefBand Technologies, LLCReliefBand Technologies, LLC – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns ReliefBand Technologies, LLC, with an inspection on April 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ReliefBand Technologies, LLC
- Inspection Date
- April 30, 2010
- Product Type
- Devices
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ID · 8e791412-3e2c-49fe-a090-527745f3a576
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660916
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(a)Complete files maintained
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.198(e)(8)Reply to complainant
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of ReliefBand Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ReliefBand Technologies, LLC
- FDA Inspection 1264619 - 2025-02-28
- FDA Inspection 1121786 - 2019-11-15
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