FDA Inspection
Apneicare LLC dba Patient Safety Inc.Apneicare LLC dba Patient Safety Inc. – FDA Inspection, Apr 12, 2024
Record Details
This FDA Inspection record concerns Apneicare LLC dba Patient Safety Inc., with an inspection on April 12, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c4a406ca-e888-4d54-aec2-6d0363c22ab0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236625
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 801.50(a)Labeling requirements for stand-alone software
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apneicare LLC dba Patient Safety Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 26, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Apneicare LLC dba Patient Safety Inc.
- FDA Inspection 1178056 - 2022-08-23
- FDA Inspection 1019443 - 2017-07-26
- FDA Inspection 924046 - 2015-05-05
- FDA Inspection 710837 - 2011-02-18
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.