WHO Slams Cadila Over GMP Concerns, Data Integrity Issues

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

The organization’s inspection of Cadila Pharmaceuticals — which produces 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 disclosed March 22.

A major sticking point of the Jan. 29 notice was data integrity, with WHO finding three critical issues related to apparently 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.

The WHO letter was issued shortly after the FDA filed a warning letter alleging GMP violations against the company — citing an apparent lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility.

In response, the company concluded that the microbiologist was “casual in his approach towards work” that showed poor quality assurance oversight. As a result, the company counselled all employees in the vaccine department on the importance of data integrity.

WHO staff also uncovered problems with environmental monitoring, as the HEPA filters in the filling and lyophilization area failed an integrity test. The company has promised to change the filters regularly over the next year.

In addition, the company was accused of neglecting to implement an appropriate quality assurance system, with sterility failures not being reported or investigated. “It is common practice by the company to investigate the sterility failure only … if more than one jar fails for sterility per batch of first or second harvest,” according to the WHO, which called this approach unacceptable.

Since the inspection, the Indian company voluntarily halted production and initiated a recall of the Lyssavac-N anti-rabies vaccines manufactured after April 2015.

Cadila still produces vaccines for the U.S. because those are produced at a separate facility, according to a company statement. The company does not expect the violations will put a dent in its U.S. business.

Stay up to date on regulatory stories like this one by subscribing to the Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.