Warning letter
Navinta, LLC: warning letter of Sep 26, 2016
FDA warning letter 498400 · New Jersey District Office
Key facts
| Reference number | 498400 |
|---|---|
| Company | Navinta, LLC |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Sep 26, 2016 |
| Posted date | Oct 3, 2016 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 314.80(c)(2), 314.80, 314.80(b), 314.98(a) |
| Inspection city | Ewing |
| Inspection ZIP | 08618 |
| Inspection start date | May 11, 2016 |
| 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: