The US Food and Drug Administration has recently classified the Maltese facilities of Spain’s Medichem S.A. as acceptable after it inspected them for the first time. During the audit, the full FDA inspection option was performed covering the Quality, Facilities and Equipment, Production and Laboratory Control Systems.

Medichem’s Malta plant was engineered and built from scratch in 2004 / 2005 and started regular production in November 2005. It obtained both the GMP certification from the Maltese National Health Authority and ISO 9001:2000 certification in February 2007.

Medichem has been selling in the US from its Spanish production site since 1986. Since then more than 25 products have been sold in this market and the Spanish facilities have regularly been inspected by the FDA with good results. With this successful inspection, the Maltese production site joins the Spanish plant as approved suppliers of high quality APIs to the US market.

Ervin Veszprémi, Medichem’s CEO commented: “We are very pleased with the outcome of this ground breaking inspection. It tells us that our traditional commitment to achieve the highest quality levels in our Spanish facilities is successfully reciprocated in our brand new Malta plant. With this excellent result we can continue to serve our customers’ high expectations from Malta, too.”