Warning letter
Dynavision International LLC: warning letter of Sep 5, 2017
FDA warning letter 525321 · New England District Office
Key facts
| Reference number | 525321 |
|---|---|
| Company | Dynavision International LLC |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Sep 5, 2017 |
| Posted date | Sep 11, 2017 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 807.81(b), 807.81(a)(3)(ii), 820 |
| Inspection city | Cincinnati |
| Inspection ZIP | 45249 |
| Inspection start date | Apr 18, 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: