FDA Inspection 1108788 — SMK Imaging LLC
The FDA completed an inspection of SMK Imaging LLC on October 23, 2019 in Elmsford, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 23, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Elmsford, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |