Warning letter
Mindray DS USA, Inc. d.b.a. Mindray North America: warning letter of Nov 29, 2012
FDA warning letter 355859 · New Jersey District Office
Key facts
| Reference number | 355859 |
|---|---|
| Company | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 29, 2012 |
| Posted date | Nov 29, 2012 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 806, 807.81(a)(3)(i), 820, 803.50(b), 806.10(a)(2), 806.10(f), 807.81(b) |
| Inspection city | Mahwah |
| Inspection ZIP | 07430 |
| Inspection start date | Jun 11, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: