FDAnews Drug Daily Bulletin
Pharmaceuticals / GMPs / Inspections and Audits

MHRA Slaps Marksans for GMP Violations

March 24, 2016

Another drugmaker has been added to India’s laundry list of GMP violators.

The UK’s Medicines & Healthcare products Regulatory Agency has issued Marksans Pharma a restricted GMP certificate following a Nov. 23 to 25, 2015 inspection of its Goa plant that revealed quality systems deficiencies.

Inspectors had paid the plant a visit last March and found a number of serious major deficiencies involving data integrity, CAPA management, change controls, product quality reviews and internal audits.