Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. It is not clear whether the company also owns an EU GMP certificate. The EudraGMDP neither lists a GMP certificate nor a GMP Non-Compliance Report. But the database is not complete yet. Still, not all countries have entered all their data into this community database. In March, the US FDA published an Inport Altert for Marck Biosciences Limited, Plot No. 876, N.H. – 8, Village Hariyala, Tal Matar, Kheda 387411, India. Now, the FDA has explained why. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility.