FDA Inspection 1102620 — X-Cel X-Ray Corp
The FDA completed an inspection of X-Cel X-Ray Corp on September 18, 2019 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
- September 18, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Crystal Lake, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |