FDA Inspection 1227489 — Nasorcap Medical, Inc.
The FDA completed an inspection of Nasorcap Medical, Inc. on Jan 22, 2024 in Venetia, PA. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Venetia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |