Warning letter
Baxter Healthcare Corp.: warning letter of Jan 17, 2014
FDA warning letter 413807 · Chicago District Office
Key facts
| Reference number | 413807 |
|---|---|
| Company | Baxter Healthcare Corp. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jan 17, 2014 |
| Posted date | Feb 10, 2014 |
| Issuing office | Chicago District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Round Lake |
| Inspection ZIP | 60073 |
| Inspection start date | Sep 10, 2013 |
| 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: