FDA Inspection
Apnea Sciences CorporationApnea Sciences Corporation – FDA Inspection, Dec 6, 2012
Record Details
This FDA Inspection record concerns Apnea Sciences Corporation, with an inspection on December 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Apnea Sciences Corporation
- Inspection Date
- December 6, 2012
- Product Type
- Devices
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ID · ee6b05fd-494f-4a70-bbc6-7f4972a25890
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 809610
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.198(e)Records of complaint investigation
Showing 10 of 12 citations.
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Other FDA inspections of Apnea Sciences Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | NAI | Los Angeles District Office | Postmarket Assurance: Medical Devices |
| August 19, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Apnea Sciences Corporation
- FDA Inspection 1229670 - 2024-09-18
- FDA Inspection 1149216 - 2021-08-19
- FDA Inspection 1060453 - 2018-07-16
- FDA Inspection 948600 - 2015-11-12
- FDA Inspection 943223 - 2015-09-18
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