Warning letter
Spectrum Medical Ltd: warning letter of Sep 29, 2023
FDA warning letter 666543 · "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality"
Key facts
| Reference number | 666543 |
|---|---|
| Company | Spectrum Medical Ltd |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 29, 2023 |
| Posted date | Apr 30, 2024 |
| Issuing office | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" |
| Product type | Devices |
| CFR sections cited | 820, 807.81(b), 807.81(a)(3)(ii) |
| Inspection city | Gloucester |
| Inspection start date | Apr 24, 2023 |
| 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: