ChemCon GmbH Successfully Passes Its Fourth FDA Inspection
4/3/2014 12:39:16 PM
ChemCon has successfully passed another inspection by the U.S. Food and Drug Administration (FDA). ChemCon, based in Freiburg, Germany, is a specialist for contract research and offers custom synthesis of active pharmaceutical ingredients (APIs) and fine chemicals. This latest FDA inspection for GMP compliance was the fourth in the 17 year history of the company. The inspection took place over four days, from March 24th to March 27nd, 2014. The inspection examined all quality assurance systems of the company relating to production, equipment, manufacturing facilities, materials and quality controls. The results of the inspection were communicated directly to ChemCon at the end of the inspection, to the delight of the whole team - no form 483 was issued, the quality systems were considered acceptable and the inspection was classified as NAI (no action indicated). This is the best result that can be given to a GMP manufacturing facility.
Malte Thoms, head of quality, commented: “Our continuously growing company has successfully completed this challenging quality inspection. This demonstrates once again that our efforts in building, maintaining and expanding a robust management system were successful and that we can demonstrate complete compliance with the current regulations.”
The Managing Directors, Dr. Raphael Vogler and Dr. Peter Gockel, were very satisfied. "This result again confirms the high quality standards of ChemCon. This great success is the result of years of excellent, hard and thorough work by the entire team" said Dr. Raphael Vogler. “The outstanding and long-term continuous commitment of the entire team contributed to this positive result."
ChemCon GmbH is a leading global supplier of high-quality active pharmaceutical ingredients (API) and fine chemicals, located in Freiburg, Germany. The company is specialized on small molecule chemistry – organic and inorganic. Based around chemical development on various stages of drug development ChemCon offers an all-in-one-hand service including full analytical support, complete documentation and outstanding quality management. Learn more about the company at www.chemcon.com.
For further questions don´t hesitate to contact me!
Tobias Timtner Tel.: +49 761-5597-310
Marketing Manager Fax: +49 761-5597-449
ChemCon GmbH E-Mail: firstname.lastname@example.org
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