Warning letter
NeuroField, Inc.: warning letter of Feb 28, 2022
FDA warning letter 621767 · Center for Devices and Radiological Health
Key facts
| Reference number | 621767 |
|---|---|
| Company | NeuroField, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
| Issue date | Feb 28, 2022 |
| Posted date | Mar 15, 2022 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 882.9, 882.1400, 807.81(b), 882.5050, 882.5050(b) |
| Inspection city | Santa Barbara |
| Inspection ZIP | 93101 |
| Inspection start date | Sep 28, 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: