Hovione sites are periodically inspected by the local and external authorities. All sites are FDA approved and with exception of New Jersey site all have EU GMP certificates.

FDA has inspected our sites for over 40 years (Portugal since 1982, Macau since 1987, New Jersey since 2007 and the Cork site we bought from Pfizer since 2008). As of 1982 we have been through 40 FDA inspections, primarily pre-approval inspections, 18 resulted in no Form 483 being issued, the remainder all had an approvable site letter issued promptly. Portugal, Macau and Ireland have all been inspected by EU medicines’ agencies either for human or veterinary use products. Japan’s PMDA routinely inspects the Portugal site, as do other national agencies. Our Macau site is also routinely inspected by the Portuguese Health Authority Infarmed (human products) and DGAV (veterinary products). We are forthcoming to support regulatory developments and our sites always engage in pilot exercises with Agencies.

Each site, as a supplier of APIs, or of intermediate drug product or of drug product (for commercial or clinical trial use), has the appropriate approvals by the local medicine agency.

The sites in Portugal and New Jersey are C-TPAT certified.

Last inspections in Loures

Health Authority Date Observations Inspection Report
FDA 2018   view report
FDA 2017 No form 483 view report
FDA 2017   view report
FDA 2016 No form 483  
FDA 2014   view report
FDA 2013 No form 483 view report
Infarmed 2021    
Infarmed 2020    
Infarmed 2018    
Infarmed 2017    
Infarmed 2016    
Infarmed 2016    
Infarmed 2014   view report
Infarmed 2013   view report
ANVISA 2019    
ANVISA 2018    
DGAV 2021    
DGAV 2018    
DGAV 2016    
DGAV 2015    
Russian FSBI VGNKI 2021    
Russian HA 2022    
Russian HA 2021    
Russian HA 2017    
Russian MoIT 2017    
Russian MoIT 2017    
Turkey HA 2016    
MFDS 2021    
KFDA 2013    

ANVISA - Brazil's National Health Surveillance Agency
DGAV - Portuguese Veterinary Products Authority
FDA - Food and Drug Administration
Infarmed - Portuguese Health Authority
KFDA - Ministry of Food and Drug Safety of the Republic of Korea
MFDS - Ministry of Food and Drug Safety of the Government of South Korea
Russian FSBI VGNKI - Russian Authority for Veterinary Products
Russian HA - Ministry of Health of the Russian Federation
Russian MoIT - Ministry of Industry and Trade of the Russian Federation
Turkey HA - Turkish Medicines and Medical Devices Agency

Last inspections in New Jersey

Health Authority Date Observations Inspection Report
FDA 2021    
FDA 2020    
FDA 2015   view report
FDA 2013 No form 483 view report

FDA - Food and Drug Administration

 

Last inspections in Macau

Health Authority Date Observations Inspection Report
FDA 2018    
FDA 2016 No form 483 view report
FDA 2013 No form 483 view report
PMDA 2017    
Infarmed 2015    

FDA - Food and Drug Administration
Infarmed - Portuguese Health Authority
PMDA - Pharmaceuticals and Medical Devices Agency of Japan

Last inspections in Cork

Health Authority Date Observations Inspection Report
FDA 2017 No form 483  
FDA 2016   view report
FDA 2014 No form 483 view report
HPRA 2018   view report
HPRA 2015   view report
HPRA 2014    
HPRA 2013    
Russian HA 2017    
KFDA 2015    

FDA - Food and Drug Administration
HPRA - Health Products Regulatory Authority
KFDA - Ministry of Food and Drug Safety (MFDS) of the Republic of Korea
Russian HA - Ministry of Health of the Russian Federation

 

Also in Quality

Hovione Policies

Hovione is dedicated to serving the Pharma Industry by providing services and products that save human lives and improve quality of life. Our team is fully committed to our Quality, HSEEn, HR and Innovation & Entrepreneurship policies.

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