Warning letter
X-Cel X-Ray Corporation: warning letter of Jun 19, 2001
FDA warning letter UCM178860 · Chicago District Office
Key facts
| Reference number | UCM178860 |
|---|---|
| Company | X-Cel X-Ray Corporation |
| Subject | Quality System Regulation for Medical Devices/Adulterated |
| Issue date | Jun 19, 2001 |
| Posted date | Jun 19, 2001 |
| Issuing office | Chicago District Office |
| Product type | Devices |
| CFR sections cited | 803, 820 |
| Country | 3 |
| Inspection city | Crystal Lake |
| Inspection ZIP | 60012-2848 |
| Inspection start date | Dec 6, 2000 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: