FDA Inspection
Extended Care Air Therapy Systems IncExtended Care Air Therapy Systems Inc – FDA Inspection, May 30, 2013
Record Details
This FDA Inspection record concerns Extended Care Air Therapy Systems Inc, with an inspection on May 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 30, 2013
- Product Type
- Devices
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ID · f9831cf5-bffa-4b85-a664-1feec297da06
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 833437
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Extended Care Air Therapy Systems Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Extended Care Air Therapy Systems Inc
- FDA Inspection 729727 - 2011-06-16
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