Warning letter
GE Medical Systems Inc. SA: warning letter of Apr 10, 2001
FDA warning letter UCM069538 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM069538 |
|---|---|
| Company | GE Medical Systems Inc. SA |
| Subject | Quality System Regulations/Full Field Digital Mammography System/Adulterated |
| Issue date | Apr 10, 2001 |
| Posted date | Apr 10, 2001 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 803, 820 |
| Country | 3 |
| Inspection city | Buc |
| Inspection start date | Dec 4, 2000 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: