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15.11.2018

ChemCon passes its fifth FDA inspection successfully without “letter 483”.

ChemCon has been inspected for the fifth time by the U.S. Food and Drug Administration (FDA) for GMP compliance. We are delighted to announce that, once again, ChemCon passed this latest inspection successfully.

No inspection is like the previous. Regulations change, priorities vary and any growing company faces the challenge of permanently maintaining and expanding a robust management system. Advancing quality and compliance is at the heart of ChemCon’s operations. Each and every member of our team commits to this high standard every day. And yet, a week of answering to an FDA inspector can keep an entire company on their toes! The more we are pleased that ChemCon once again received the best possible result for a GMP manufacturing facility: No warning letter 483 issued. Dr. Raphael Vogler, CEO: “This is the result of continuous hard work and cooperation of the entire team. Our first FDA inspection dates back to the year 2000. I am very proud that we keep holding this top standard for some many years now.”

During the inspection from October 22-26, 2018, all quality assurance systems relating manufacturing and analytical facilities, equipment, production, quality control, validation protocols and stability studies were examined thoroughly. Data integrity is becoming increasingly more important in the GMP environment and was also an integral part of the agenda.

Overall, this latest of many GMP inspections in the company’s 20-year history confirms that our customers can trust in ChemCon’s core competence at any time: The fully GMP-compliant development, manufacturing, quality control and release of drug substances.

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