Warning letter
Rapid Diagnostics, Division Of Mp Biomedicals, Llc: warning letter of Aug 24, 2015
FDA warning letter 460425 · San Francisco District Office
Key facts
| Reference number | 460425 |
|---|---|
| Company | Rapid Diagnostics, Division Of Mp Biomedicals, Llc |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Aug 24, 2015 |
| Posted date | Sep 1, 2015 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3)(ii) |
| Inspection city | Burlingame |
| Inspection ZIP | 94010 |
| Inspection start date | Feb 19, 2015 |
| 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: