FDA Inspection 938468 — OndaMed, Inc.
The FDA completed an inspection of OndaMed, Inc. on Aug 17, 2015 in Washingtonville, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Washingtonville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |