24 Mar 2016
World Health Organization (WHO) cited violations of found “several major deviations” from standard procedures manufacturing and clinical standards.
Cadila stopped production of the vaccine at the plant and began a recall of all batches it made there since April 2015 after getting the notice in November, the WHO said. It also sells the vaccine in India.
Cadila’s staff at the plant falsified multiple quality control records and reports to hide contamination, and failed to implement a quality assurance system, the WHO said. Sterility failures were also not reported, nor investigated, the agency said among a series of concerns outlined in the letter. Microbiologists on site was “casual in his approach towards work”, and there was a “lack of supervision by the laboratory head,” the WHO notice said.