Warning letter
Animas Corporation: warning letter of Feb 24, 2005
FDA warning letter UCM075301 · Philadelphia District Office
Key facts
| Reference number | UCM075301 |
|---|---|
| Company | Animas Corporation |
| Subject | CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated |
| Issue date | Feb 24, 2005 |
| Posted date | Feb 24, 2005 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 803.50(b), 803, 803.50, 803.50(a)(1), 803.50(a)(2), 820 |
| Country | 3 |
| Inspection city | West Chester |
| Inspection ZIP | 19380-3428 |
| Inspection start date | Sep 2, 2004 |
| 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: