FDA Inspection 944645 — Oxysure Systems, Inc.
The FDA completed an inspection of Oxysure Systems, Inc. on September 28, 2015 in Frisco, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 28, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Frisco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |