Warning letter
Galaxy Medical Inc: warning letter of Jan 14, 2003
FDA warning letter UCM147269 · Florida District Office
Key facts
| Reference number | UCM147269 |
|---|---|
| Company | Galaxy Medical Inc |
| Subject | CGMP/Drug/Deviations/Adulterated |
| Issue date | Jan 14, 2003 |
| Posted date | Jan 14, 2003 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 210, 211.22, 211.68, 211.160, 211.165, 211.188, 211.192, 211.194, 211.198, 211.25(a), 211.84(d)(2), 211.130(c) and 1 more |
| Country | 3 |
| Inspection city | Ft Lauderdale |
| Inspection ZIP | 33309-8003 |
| Inspection start date | Sep 24, 2002 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: