Warning letter
Baxter Healthcare S.A. /dba Baxter Healthcare of Puerto Rico [ARCHIVED]: warning letter of Jan 20, 2011
FDA warning letter 134330 · San Juan District Office
Key facts
| Reference number | 134330 |
|---|---|
| Company | Baxter Healthcare S.A. /dba Baxter Healthcare of Puerto Rico [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 20, 2011 |
| Posted date | Jan 20, 2011 |
| Issuing office | San Juan District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.94(b), 314.81(b)(1)(i) |
| Inspection city | Jayuya |
| Inspection ZIP | 00664 |
| Inspection start date | Jul 14, 2010 |
| 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: