Warning letter
Neurotris, Inc. dba A1 Engineering: warning letter of Oct 27, 2023
FDA warning letter 659244 · Center for Devices and Radiological Health
Key facts
| Reference number | 659244 |
|---|---|
| Company | Neurotris, Inc. dba A1 Engineering |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Oct 27, 2023 |
| Posted date | Nov 7, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 890.5525, 807.81(b)(1), 820, 882.1275, 882.1320, 807.81(a), 882.5890, 890.5850 |
| Inspection city | Irvine |
| Inspection ZIP | 92618 |
| Inspection start date | Apr 4, 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: