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

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

ANVISA - Brazil's National Health Surveillance Agency
FDA - Food and Drug Administration
PMDA - Pharmaceuticals and Medical Devices Agency of Japan
SFDA - Saudi Food & Drug Authority
TGA - Therapeutic Goods Administration

Last inspections in Macau

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

Last inspections in Cork

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