Warning letter
Nephros, Inc.: warning letter of May 27, 2015
FDA warning letter 449134 · New Jersey District Office
Key facts
| Reference number | 449134 |
|---|---|
| Company | Nephros, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 27, 2015 |
| Posted date | May 27, 2015 |
| Issuing office | New Jersey District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a), 803, 803.20(c)(1), 803.52(b)(3), 820, 803.50(b) |
| Inspection city | Whippany |
| Inspection ZIP | 07981 |
| Inspection start date | Oct 8, 2014 |
| 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: