FDA Inspection
Apneicare LLC dba Patient Safety Inc.Apneicare LLC dba Patient Safety Inc. – FDA Inspection, Jul 26, 2017
Record Details
This FDA Inspection record concerns Apneicare LLC dba Patient Safety Inc., with an inspection on July 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · caed01d1-0f6a-4094-ae60-e6ef7d87ef17
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1019443
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Apneicare LLC dba Patient Safety Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 23, 2022 | VAI | Center for Devices and Radiological Health | Compliance: 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 1236625 - 2024-04-12
- FDA Inspection 1178056 - 2022-08-23
- FDA Inspection 924046 - 2015-05-05
- FDA Inspection 710837 - 2011-02-18
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