Warning letter
Fehling Instruments GmbH & Co. KG: warning letter of Oct 13, 2015
FDA warning letter UCM514991 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM514991 |
|---|---|
| Company | Fehling Instruments GmbH & Co. KG |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Oct 13, 2015 |
| Posted date | Oct 13, 2015 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 803.50(a), 807.81(b) |
| Country | 3 |
| Inspection city | Karlstein A. Main |
| Inspection start date | Jun 15, 2015 |
| 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: