Express Pharma

US FDA issues warning letter to Mylan


Inspectors found ‘significant violations’ in its three manufacturing facilities in Bengaluru

The US Food & Drug Administration (US FDA) has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka.

According to a PTI report, the US regulator said its inspectors found ‘significant violations’ in the three manufacturing facilities in Bengaluru of the company, which is an arm of US-based Mylan.

Of the three units, two plants belonged to Agila Specialties, which Mylan had acquired from Strides Arcolab in 2013. The other unit is owned by Mylan Laboratories.

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