FDA Inspection
Sleepsafe Beds, LLCSleepsafe Beds, LLC – FDA Inspection, Apr 19, 2018
Record Details
This FDA Inspection record concerns Sleepsafe Beds, LLC, with an inspection on April 19, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 5a32b493-4689-43af-9bad-50cecb8ed970
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048743
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sleepsafe Beds, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2023 | NAI | 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 1222762 - 2023-10-19
- FDA Inspection 794538 - 2012-08-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.