Mylan warned by US FDA over Indian production facilities

The US Food and Drug Administration has warned Netherlands-incorporated generic drugmaker Mylan (Nasdaq: MYL) that three of its pharmaceutical manufacturing facilities in India have been identified as having significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.

Two of the facilities relate to Mylan’s Indian subsidiary Agila Specialties, which it acquired in 2013 for around $1.6 billion, and one to Mylan Laboratories. Some of the violations cited were failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products - including the use of torn gloves - and poor monitoring of personnel. “Several violations are recurrent and long-standing,” the warning letter stated.

These violations cause Mylan’s drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.C 351(a)(2)(B). 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 FDA stated.