FDA Inspection 957017 — SomnoMed Phillipines Inc.
The FDA completed an inspection of SomnoMed Phillipines Inc. on Jan 28, 2016 in Makati City. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Makati City (Philippines)
Citations
| ID | CFR | Description |
|---|---|---|
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3838 | 21 CFR 820.40(a) | Document review procedures, designated individual |