Inspections History

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 30 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 37 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 GGAV (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 2016
Infarmed 2014 view report
Infarmed 2013 view report
ANVISA 2019
ANVISA 2018
DGAV 2018
DGAV 2016
DGAV 2015
Russian HA 2017
Turkey HA 2016
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 (MFDS) of the Republic of Korea
Russian HA - Ministry of Health of the Russian Federation
Turkey HA - Turkish Medicines and Medical Devices Agency

Last inspections in New Jersey

Health Authority Date Observations Inspection Report
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.