Umicore Argentina further improves its quality systems after successful FDA audit

Precious Metals Chemistry

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. 

Please click here for more information on the 483 report and the comments of the FDA Auditor. 


      Umicore uses certain monitoring and tracking technologies such as cookies. These technologies are used in order to maintain, provide and improve our services on an ongoing basis, and in order to provide our web visitors with a better experience.

      By clicking on the "Accept all" button you agree to the use of these cookies while using the website. For further information regarding how we use cookies and other tracking technologies, please see section 11 of our website privacy notice

          Necessary cookies are essential and help you navigate our website. This helps to support security and basic functionality and are necessary for the proper operation of our website, so if you block these cookies we cannot guarantee your use or the security during your visit.

          Cookies that help us to understand the behaviour of users of our website. This allows us to continuously improve our website to provide the best information in support of our project aims. These cookies also help us understand the effectiveness of our website. For instance these cookies tell us which pages visitors go to most often and if they get error messages from web pages.

          Cookies that deliver content to you based on your interests, which are assumed from your browsing history. Most Targeting Cookies track users via their IP address and, thus, may collect some Personal Data. Personal Data collected by Targeting Cookies may be shared with third parties, such as advertisers.