Warning letter
Baxter Healthcare Corporation: warning letter of Aug 11, 2000
FDA warning letter UCM068723 · Chicago District Office
Key facts
| Reference number | UCM068723 |
|---|---|
| Company | Baxter Healthcare Corporation |
| Subject | Aseptic Parenteral Manufacturing/cGMP Violations |
| Issue date | Aug 11, 2000 |
| Posted date | Aug 11, 2000 |
| Issuing office | Chicago District Office |
| Product type | Unknown |
| CFR sections cited | 21, 211, 211.22, 211.42, 211.58, 211.100, 211.110, 211.113, 211.115, 211.160, 211.165, 211.192 and 2 more |
| Country | 3 |
| Inspection city | Round Lake |
| Inspection ZIP | 60073-9799 |
| Inspection start date | Sep 7, 1999 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
- 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: