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Dr. Reddy's Receives FDA Warning Letter

From Associated Press (June 14, 2011)

Generic drug maker Dr. Reddy's Laboratories Ltd. said Tuesday it received a four-item warning letter from the Food and Drug Administration over a Mexican location that produces drug ingredients.

The Indian company said the FDA inspected its Cuernavaca, Mexico, plant in November and issued a Form 483 with observations.

A brief statement from the company did not elaborate on the observations. These forms are issued when an inspection finds deficiencies at a pharmaceutical manufacturing plant.

Dr. Reddy's said it responded to the form and started some corrective actions, but regulators have asked for additional data and corrective actions. The company said it will work with the FDA to resolve the matters in the warning letter.

U.S.-traded shares of Dr. Reddy's climbed 15 cents to $34.78.


Posted: June 2011