FDA Inspection 833437 — Extended Care Air Therapy Systems Inc
The FDA completed an inspection of Extended Care Air Therapy Systems Inc on May 30, 2013 in Roseville, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Roseville, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 537 | 21 CFR 820.70(a) | Production processes |