Contract Services

GMP Inspections – APIs and Drug Products

GMP Inspections – APIs and Drug Products

Since Fuji Chemical Industries Co., Ltd. was first inspected by US FDA in 1981, we have been inspected by numerous domestic and international authorities.

Our manufacturing and quality control systems, which comply with domestic and international GMP standards based on this extensive inspection experience, have been highly praised by our customers.

Inspection History

History since 2016

Year Month Insepcted by Scope
2016 January Toyama
Prefecture		 Pre-Inspection for Drug
Manufacturer License Renewal		 API・drug product・
drug intermediate
June TMMDA Pre-approval Inspection drug intermediate
September US FDA Routine Inspection API
November PMDA Routine Inspection API
GMP Compliance Inspection drug intermediate
2017 October Toyama
Prefecture		 GMP Compliance Inspection for
Export Products and Others 		 API・drug product
2018 March US FDA Pre-approval Inspection drug intermediate
2019 January CFDI Pre-approval Inspection drug intermediate
June ANVISA Pre-approval Inspection drug intermediate
2020 February Toyama  GMP Compliance Inspection for
Export Products and Others		 API・drug product・
drug intermediate
February Minpromtorg
of Russia		 Pre-approval Inspection drug intermediate
2021 July Toyama
Prefecture		 Pre-Inspection for Drug
Manufacturer License Renewal		 API・drug product・
drug intermediate
2022 February PMDA Routine Inspection drug intermediate
September ANVISA Routine Inspection drug intermediate
2023 February Toyama Prefecture GMP Compliance Inspection drug product
July Toyama Prefecture GMP Compliance Inspection for
Export Products and Others　		 API・drug product・
drug intermediate
September US FDA Routine Inspection API
October Minpromtorg
of Russia		 Routine Inspection drug intermediate

 

Inspection History by US FDA

We have been inspected 11 times by US FDA since 1981.
There was no major observation found at the recent FDA inspection in 2023. The finding was NAI (No Action Indicated).

 

Others

We have abundant experiences in inspections by international authorities such as EU, South Korea, China, Brazil, and Russia, as well as domestic authorities such as Toyama Prefecture and the Pharmaceuticals and Medical Devices Agency.