Warning letter
Smiths Medical ASD Inc.: warning letter of Oct 1, 2021
FDA warning letter 617147 · Center for Devices and Radiological Health
Key facts
| Reference number | 617147 |
|---|---|
| Company | Smiths Medical ASD Inc. |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Oct 1, 2021 |
| Posted date | Nov 23, 2021 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.3, 806.10, 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.18(b)(1)(i), 803.20(a)(3), 803.50(a)(2), 820 |
| Inspection city | Minneapolis |
| Inspection ZIP | 55442 |
| Inspection start date | Feb 23, 2021 |
| 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: