Umicore Argentina further improves its quality systems after successful FDA audit

Umicore Argentina plant, which produces a series of anti-cancer active pharmaceutical ingredients, was successfully audited for the second time by the US Food and Drug Administration (FDA) in May 2018. The auditor concluded that the plant was run according the FDA standards and the plant remained FDA approved. The auditor only mentioned in his 483 report (official FDA audit report) four points to be improved in the quality systems of the plant. No warning letter was issued by the FDA.  

These comments have been taken seriously and adjustments have been implemented. The quality of the products we manufacture and the maximum safety of the patients being treated with the final drugs produced out of our active pharmaceutical ingredients remain our constant focus and the improvements recommended by the FDA Auditor contribute to bring them to an even higher level. 

The areas of improvements relate to incorrect or incorrectly applied control procedures or equipment used at early stage of the manufacturing process as well as to the area of microbiology where a better training of existing procedures will improve our quality system. The inspector furthermore identified the opportunity to improve laboratory records.

Final quality controls of the manufactured active pharmaceutical ingredients have proven that their safety and quality have always remained at highest required level.