FDA Inspection
The Snore Reliever Company LLCThe Snore Reliever Company LLC – FDA Inspection, Aug 29, 2024
Record Details
This FDA Inspection record concerns The Snore Reliever Company LLC, with an inspection on August 29, 2024, issued by the Florida District Office, covering medical devices & rad health.
- Inspection Date
- August 29, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 33f70a81-3a1a-44d6-9737-b213730d6070
Inspection Facts
- Inspection number
- 1248984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of The Snore Reliever Company LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2020 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 25, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for The Snore Reliever Company LLC
- FDA Inspection 1116928 - 2020-02-05
- FDA Inspection 853465 - 2013-10-25
- FDA Inspection 786643 - 2012-06-12
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