The US Food and Drug Administration has identified serious lapses in the Indian pharmaceutical company.
According to the American media report, deficiencies in cleaning and storage control have been identified in the Indian pharmaceutical company’s plant.
The FDA says that laboratory controls at the Indian pharmaceutical company were not scientifically sound and that the density control equipment at the plant was not kept clean.
The FDA also says that the lapses at the Indian company reflect inadequate management oversight.
According to American media reports, there have been widespread deficiencies in Indian pharmaceutical companies for some years.
Dozens of children have died from adulterated Indian medicines in Gambia and Uzbekistan.
It should be remembered that the Indian company was asked to remove the deficiencies by the FDA earlier.
The World Health Organization had also issued a global alert on substandard Indian medicines in December 2022.