Warning letter
Raritan Pharmaceuticals, Inc.: warning letter of Jun 20, 2017
FDA warning letter 516099 · New Jersey District Office
Key facts
| Reference number | 516099 |
|---|---|
| Company | Raritan Pharmaceuticals, Inc. |
| Subject | CGMP/Manufacturing, Processing, packing, or Holding/Misbranding |
| Issue date | Jun 20, 2017 |
| Posted date | Jun 27, 2017 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.84(d)(2), 211.100(a) |
| Inspection city | East Brunswick |
| Inspection ZIP | 08816 |
| Inspection start date | Sep 29, 2016 |
| Letter on fda.gov | fda.gov |
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: