Since receiving the first FDA inspection in 1981, Fuji Chemical has received high praise from customers for its GMP compliance. All of the GMP manufacturing operations are carried under our robust system. We maintain our GMP compliance at the highest level based on these numerous inspections.
Inspection Record
Inspections since 2016
| Year | Month | Inspected by |
Scope |
|---|---|---|---|
| 2016 | January | Toyama Prefecture (local) |
Routine GMP inspection for all drugs & APIs |
| June | TMMDA (Turkey) |
Pre-approval Inspection for drug intermediate | |
| September | US FDA | Routine GMP Inspection for API | |
| November | PMDA (Japan) |
Routine GMP Inspection for API | |
| GMP Compliance Review for drug intermediate | |||
| 2017 | October | Toyama Prefecture |
Routine GMP Inspection for API, and DP |
| 2018 | March | US FDA | Pre-approval Inspection for drug intermediate |
| 2019 | January | CFDI (China) |
Post-approval Inspection for drug intermediate |
| June | ANVISA (Brazil) |
Pre-approval Inspection for drug intermediate | |
| 2020年 | February | Toyama Prefecture (local) |
Pre-approval Inspection for drug intermediate |
| February | Ministry of Industry and Trade of the Russian Federation |
Pre-approval Inspection for drug intermediate |
FDA Inspection
Fuji has undergone FDA inspections in 1981, 1983, 1985, 1989, 1995, 1999, 2004, 2010, 2013 and 2018. The scope is APIs and a drug intermediate.
EMA Inspection
Fuji has received EMA inspection in 2012. The scope is APIs.
Other inspections.
We have received numerous inspection by the local authority (Toyama Prefecture) and Pharmaceuticals and Medical Devices Agency (Japan) as well as other oversea authorities.
