Warning letter
Edwards Pharmaceuticals, Inc [ARCHIVED]: warning letter of Feb 8, 2010
FDA warning letter 85627 · New Orleans District Office
Key facts
| Reference number | 85627 |
|---|---|
| Company | Edwards Pharmaceuticals, Inc [ARCHIVED] |
| Subject | New Drug/Adulterated |
| Issue date | Feb 8, 2010 |
| Posted date | Feb 8, 2010 |
| Issuing office | New Orleans District Office |
| Product type | Drugs |
| CFR sections cited | 201.5, 201.115 |
| Inspection city | Paoli |
| Inspection ZIP | 19301 |
| Inspection start date | Dec 15, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- NAI 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: