Warning letter
DRG Instruments GmbH: warning letter of Mar 31, 2025
FDA warning letter 700918 · Center for Devices and Radiological Health
Key facts
| Reference number | 700918 |
|---|---|
| Company | DRG Instruments GmbH |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Mar 31, 2025 |
| Posted date | May 27, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.3(o)(2)(ii), 803.17, 803.17(a)(1), 803.17(a)(3), 803.17(b), 807.81(a)(1), 807.81(a)(3), 807.81(a)(3)(i), 803.11(a), 807.81(b) and 1 more |
| Inspection city | Marburg |
| Inspection start date | Nov 4, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: