Warning letter
Hemarus LLC: warning letter of Oct 8, 2024
FDA warning letter 688656 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 688656 |
|---|---|
| Company | Hemarus LLC |
| Subject | CGMP/Blood & Blood Components/Adulterated |
| Issue date | Oct 8, 2024 |
| Posted date | Oct 15, 2024 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 640.65(b)(2)(i), 606, 640, 606.20(b), 606.100(c), 606.100(b) |
| Inspection city | Lauderhill |
| Inspection ZIP | 33313 |
| Inspection start date | Apr 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: