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 26 FDA inspections, primarily pre-approval inspections, 13 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 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

Last inspections in New Jersey

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

Last inspections in Macau

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

Last inspections in Cork

Health Authority Date Observations Inspection Report
FDA 2016   view report
FDA 2014 No form 483 view report
HPRA 2015   view report

 

FDA - Food and Drug Administration
HPRA - Health Products Regulatory Authority
Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.

 

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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.