WHO Slaps Cadila With Letter Over GMP Violations, Data Integrity Issues

Shortly after receiving an FDA warning letter for major quality deficiencies, Indian drugmaker Cadila Pharmaceuticals was slammed for data integrity issues and GMP violations by the World Health Organization.

The inspection — involving the human rabies vaccines VaxiRab N and Lyssavac N — uncovered a number of critical and major observations at the company’s Moraiya plant in Gujarat, according to a notice of concern issued Jan. 29.

A major sticking point was data integrity, with WHO finding three critical issues related to apparent fraudulent data:

• False results in the quality control records and reports;
• Inaccurately recorded and reported colony forming unit counts; and
• Out-of-specification settle plate counts.