Warning letter
MAK-SYSTEM S.A. International Group: warning letter of Feb 6, 2003
FDA warning letter UCM147298 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM147298 |
|---|---|
| Company | MAK-SYSTEM S.A. International Group |
| Subject | Quality System Regulation/Adulterated |
| Issue date | Feb 6, 2003 |
| Posted date | Feb 6, 2003 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| Country | 3 |
| Inspection city | Roissy C.D.G. |
| Inspection start date | Oct 7, 2002 |
| Letter on fda.gov | web.archive.org |
At a glance
- 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: