CHEMCON does it again: Flawless FDA Inspection

19-Jul-2011 - Germany

ChemCon´s facility in Freiburg, Germany has been cleared for the production of active pharmaceutical ingredients (APIs) by the US Food & Drug Administration FDA. According to the US regulator, the site is fully compliant with Current Good Manufacturing Practices (CGMP). FDA completed the renewal inspection without any written citation, on July 7, 2011.

ChemCon

ChemCon headquarters in Freiburg, Germany

“We are very proud of this achievement” states Raphael Vogler, CEO of ChemCon GmbH. “It adds to our outstanding track record and is a result of our continuous striving for excellence. ChemCon had already been successfully audited by the FDA in 2000 and 2007, allowing us to supply commercial APIs to the US market. Our company´s world-class Quality Assurance Management is audited by customers and local authorities quite often, but a successful FDA inspection is always the icing on the cake”.

All API batches produced at the ChemCon site bearing a Certificate of Compliance are manufactured in accordance with current Good Manufacturing Practices as set forth in 21 CFR Parts 210, 211 and ICH Q7. The company is certified to comply with ISO 9001:2008 and was four-times successfully audited by German local authorities.

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