Warning letter
ZOLL Medical Corporation: warning letter of Apr 30, 2026
FDA warning letter 711320 · Center for Devices and Radiological Health
Key facts
| Reference number | 711320 |
|---|---|
| Company | ZOLL Medical Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Apr 30, 2026 |
| Posted date | Jun 16, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803, 803.3(o), 803.50(a)(2) |
| Inspection city | Chelmsford |
| Inspection ZIP | 01824 |
| Inspection start date | Feb 27, 2025 |
| 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: