FDA Inspection 1037620 — O2 Concepts, LLC
The FDA completed an inspection of O2 Concepts, LLC on Jan 10, 2018 in Middlebury, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 10, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Middlebury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |