German Regulators Discover 35 Issues with Lab in India
Regulators in Germany have cited a lab in India with litany of GMP violations and have recommended a prohibition of supply.
The German regulator Landesportal Schleswig Holstein-Landesamt Für Soziale Dienste found 35 GMP violations at Artemis Biotech in India. The company, a division of Themis Medicare, manufactures the cholesterol drug Simvastatin.
Five of the violations are listed as major deficiencies, including repackaging operations being conducted without any documentation or oversight, as well as data integrity issues.