Warning letter
Globus Medical, Inc.: warning letter of Jul 15, 2024
FDA warning letter 685606 · Office of Medical Device and Radiological Health Division I
Key facts
| Reference number | 685606 |
|---|---|
| Company | Globus Medical, Inc. |
| Subject | CGMP/QSR/Drug/Medical Devices/Adulterated |
| Issue date | Jul 15, 2024 |
| Posted date | Aug 13, 2024 |
| Issuing office | Office of Medical Device and Radiological Health Division I |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.18(b)(1)(iii), 803.50(a)(1), 803.50(a)(2), 820 |
| Inspection city | Norristown |
| Inspection ZIP | 19403 |
| Inspection start date | Feb 15, 2024 |
| Letter on fda.gov | fda.gov |
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: