Warning letter
Elite Laboratories Inc.: warning letter of Aug 25, 2016
FDA warning letter 496551 · New Jersey District Office
Key facts
| Reference number | 496551 |
|---|---|
| Company | Elite Laboratories Inc. |
| Subject | Postmarketing Adverse Drug Experience (PADE) |
| Issue date | Aug 25, 2016 |
| Posted date | Sep 26, 2016 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 314.80(b), 314.98(a), 314.80, 314.80(c)(1)(ii) |
| Inspection city | Northvale |
| Inspection ZIP | 07647 |
| Inspection start date | Jan 5, 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: