Warning letter
Non-Invasive Monitoring Systems, Inc. [ARCHIVED]: warning letter of Mar 18, 2011
FDA warning letter 117929 · Center for Devices and Radiological Health
Key facts
| Reference number | 117929 |
|---|---|
| Company | Non-Invasive Monitoring Systems, Inc. [ARCHIVED] |
| Subject | Premarket Approval/Misbranded/Adulterated |
| Issue date | Mar 18, 2011 |
| Posted date | Mar 18, 2011 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b), 890.9, 890.5975 |
| Inspection city | Miami |
| Inspection ZIP | 33137 |
| Inspection start date | Mar 24, 2010 |
| Letter on fda.gov | web.archive.org |
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: