FDA Inspection 1163948 — X-Cel X-Ray Corp
The FDA completed an inspection of X-Cel X-Ray Corp on March 4, 2022 in Crystal Lake, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 4, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Crystal Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3159 | 21 CFR 820.184 | DHR content |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |