USFDA issues warning letter to Mylan for lapses in three units at Karnataka
USFDA has issued a warning letter to Mylan Laboratories for its three plants in Karnataka. The US Food & Drug Administration (USFDA) issued the letter due to violation of current good manufacturing practice (CGMP) norms.
USFDA said that "At all three sites, we identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals". "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," the US health regulator . On the Mylan's Bengaluru facility, the USFDA said "The significant violations included failure of the company to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes.