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USFDA has issued a warning letter to Mylan for lapses at 3 units

A warning letter has been issued by the US Food & Drug Administration (USFDA) to Mylan Laboratories for the violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka.

The US regulator said that its inspectors found ” significant violations” in the three manufacturing facilities in Bengaluru of the company, that is an arm of US- based Mylan Inc.

USFDA said that “At all three sites, we identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

It further said, “The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with CGMP.”

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