FDA Inspection 1098901 — Panoramic Corp.
The FDA completed an inspection of Panoramic Corp. on August 7, 2019 in Fort Wayne, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Fort Wayne, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |