Certifications & Inspections
Certifications & Inspections
Jordanian Food & Drug Administration (JFDA)
U.S. Food & Drug Administration (USFDA) Fifth consecutive inspection with NO 483 Comments
Federal Institute for Drugs & Medical Devices/ Germany (BfArM)
undesamt für Sicherheit im Gesundheitswesen/ Austrian (BASG)
French National Agency for Medicines & Health Products Safety (ANSM)
European Medicines Agency (EMA)
Austrian Agency for Health& Food Safety (AGES)
Spanish Medicines & Medical Devices Agency (AEMPS)
French Agency for the Safety of Health Products (AFSSAPS)
Inspection History (Last 5 years)
| Regulatory Authority | Visit Date | Visit Outcome |
|---|---|---|
| GCC | 19-Feb-24 | Re-accreditation Obtained |
| USFDA (5th inspection) | 06-Aug-23 | Passed (No 483 comments) |
| USFDA | 08-Dec-19 | Passed (No 483 comments) |
| USFDA | 28-Oct-19 | Passed (No 483 comments) |
| EMA | 25-Aug-19 | Passed — The inspectors recommended using the reported data for evaluation by the assessors |