FDA Inspection
Sleepsafe Beds, LLCSleepsafe Beds, LLC – FDA Inspection, Oct 19, 2023
Record Details
This FDA Inspection record concerns Sleepsafe Beds, LLC, with an inspection on October 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 23a8b779-bb4e-438e-9f79-1d2c02caf6f0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1222762
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Sleepsafe Beds, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Sleepsafe Beds, LLC
- FDA Inspection 1048743 - 2018-04-19
- FDA Inspection 794538 - 2012-08-09
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