Warning letter
Ulrich GmbH & Co. KG: warning letter of Aug 15, 2013
FDA warning letter 407860 · Center for Devices and Radiological Health
Key facts
| Reference number | 407860 |
|---|---|
| Company | Ulrich GmbH & Co. KG |
| Subject | Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded |
| Issue date | Aug 15, 2013 |
| Posted date | Aug 15, 2013 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17(a), 820, 803.50(b), 803, 803.3 |
| Inspection city | Ulm |
| Inspection start date | Apr 29, 2013 |
| 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: