Warning letter
SynCardia Systems LLC: warning letter of Apr 3, 2018
FDA warning letter 537226 · Los Angeles District Office
Key facts
| Reference number | 537226 |
|---|---|
| Company | SynCardia Systems LLC |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Apr 3, 2018 |
| Posted date | Apr 3, 2018 |
| Issuing office | Los Angeles District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 803, 803.50(a)(1) |
| Inspection city | Tucson |
| Inspection ZIP | 85713 |
| Inspection start date | Aug 14, 2017 |
| 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: