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FDAnews Drug Daily Bulletin

Italian Regulators Slam Two Indian Drugmakers Over GMP Problems

May 25, 2016

Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues.

The Italian Medicines Agency recommended that any European regulatory authorities that encounter drugs produced at JP Laboratories’ Maharashtra facility and Krebs Biochemicals & Industries plant in Andhra Pradesh prohibit their use or importation.

The noncompliance report for JP Laboratories found 28 GMP deficiencies at the active substance production plant, nine of which it classified as major. The most significant problems involved quality management issues, data integrity concerns and a lack of production controls.

 

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