US FDA pulls up Mylan for manufacturing violations at Andhra plant

The significant violations included failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials American health regulator US FDA has pulled up Mylan Laboratories for violation of good manufacturing norms, including lapses in handling raw materials and issues related with cleaning of equipment, at its Andhra Pradesh-based manufacturing facility.

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In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company'Unit 8 in G Chodavaram village in Vizianagaram.

"This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API)," the USFDA said.