Warning letter
River's Edge Pharmaceuticals, LLC [ARCHIVED]: warning letter of May 20, 2010
FDA warning letter 76864 · Atlanta District Office
Key facts
| Reference number | 76864 |
|---|---|
| Company | River's Edge Pharmaceuticals, LLC [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | May 20, 2010 |
| Posted date | May 20, 2010 |
| Issuing office | Atlanta District Office |
| Product type | Drugs |
| CFR sections cited | 211.22(a), 211.25(a), 211.160(b), 211.198(a), 211.198(b)(3) |
| Inspection city | Suwanee |
| Inspection ZIP | 30024 |
| Inspection start date | Jul 13, 2009 |
| 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: