FDA Inspection 1257092 — Norman Noble Inc
The FDA completed an inspection of Norman Noble Inc on December 19, 2024 in Highland Heights, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Highland Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |