FDA Tells Wockhardt To Assess Drug Facilities

Law360, New York (December 3, 2013, 8:54 PM EST) -- U.S. regulators who found shortcomings with Indian drugmaker Wockhardt Ltd.’s corrective measures to address purported manufacturing standard violations at two major facilities asked the embattled generics giant to outline plans to fix potential deficiencies at its facilities around the world, according to a letter made public Tuesday.

The U.S. Food and Drug Administration, which only last week limited imports from one of the largest facilities of the Mumbai-based firm, said in a letter posted Tuesday that it “strongly recommends” that Wockhardt carry out a global assessment...
To view the full article, register now.