FDA Inspection 1067339 — OndaMed, Inc.
The FDA completed an inspection of OndaMed, Inc. on Sep 28, 2018 in Washingtonville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 28, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Washingtonville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |