Warning letter
Magellan Diagnostics, Inc.: warning letter of Oct 23, 2017
FDA warning letter 532743 · New England District Office
Key facts
| Reference number | 532743 |
|---|---|
| Company | Magellan Diagnostics, Inc. |
| Subject | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Issue date | Oct 23, 2017 |
| Posted date | Oct 23, 2017 |
| Issuing office | New England District Office |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3), 7, 803, 803.17, 803.20, 806, 806.10, 803.12(a), 803.17(a)(3), 803.17(b), 803.50(a)(2), 820 and 2 more |
| Inspection city | North Billerica |
| Inspection ZIP | 01862 |
| Inspection start date | May 10, 2017 |
| Letter on fda.gov | fda.gov |
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: