Warning letter
Animas Corporation [ARCHIVED]: warning letter of Dec 27, 2011
FDA warning letter 242654 · Philadelphia District Office
Key facts
| Reference number | 242654 |
|---|---|
| Company | Animas Corporation [ARCHIVED] |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | Dec 27, 2011 |
| Posted date | Dec 27, 2011 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 803.53, 803, 803.17, 803.50, 803.50(a)(1), 820 |
| Inspection city | West Chester |
| Inspection ZIP | 19380 |
| Inspection start date | Jul 18, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: