Hovione Loures is a certified manufacturing plant inspected by the Health Authorities and the site has an Environmental Management System (EMS) in accordance with ISO14001 that requires a continuous improvement of the environmental performance.

Portuguese Health Authority

Hovione Loures site is regularly inspected by the Portuguese Health Authority agency, INFARMED, and is approved for the manufacture of Active Pharmaceutical Ingredients as well as for Investigational Medicinal Products. The last inspection took place in January 2010.

USA Health Authority

Hovione was first approved by the FDA in 1982, since then, in the three manufacturing sites, no fewer than 15 FDA inspections over a 23-year period were performed. Over that time, no warning letter has ever been issued and, of the 10 Form 483s received, all were addressed satisfactorily within 30 days.

Hovione Loures last FDA inspection took place in September 2009 and the last seven inspections have been pre-approval inspections.

Client Audits

Hovione welcomes customers to visit our facilities, allowing them to audit projects or simply view the manufacturing process in person. Frequent customer and regulatory audits further contribute to assure compliance. Over the last 3 years our facilities have been inspected by more than 50 different audit teams, with about half conducted by repeat-customers carrying out repeat-audits. Being "audited into best practice" is part of our business model and a commitment to continuous improvement is a cornerstone of the Company's culture.