Warning letter
Baxter Healthcare Corporation: warning letter of May 31, 2013
FDA warning letter 386558 · Atlanta District Office
Key facts
| Reference number | 386558 |
|---|---|
| Company | Baxter Healthcare Corporation |
| Subject | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated |
| Issue date | May 31, 2013 |
| Posted date | May 31, 2013 |
| Issuing office | Atlanta District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.67(a), 211.94(b), 211.160(b), 211.165(a), 314.81 |
| Inspection city | Jayuya |
| Inspection ZIP | 00664 |
| Inspection start date | Mar 13, 2013 |
| 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: