FDA Inspection 1233164 — VisionAir Solutions LLC
The FDA completed an inspection of VisionAir Solutions LLC on Mar 14, 2024 in Akron, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 14, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Akron, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |