Drugmaker Dr. Reddy's Laboratories Ltd. has received five observations from the U.S. health regulator for its active pharmaceutical ingredient plant at Medak in Telangana.
The observations are related to procedures and facilities maintenance, Dr. Reddy's said in its stock exchange filing. It did not give specific details about the observations.
“We will address them comprehensively within stipulated time,” the company added.
A Form 483 is issued to a firm's management at the conclusion of an inspection by the U.S. Food and Drug Administration when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. It notifies the company's management of objectionable conditions at
The stock closed 0.7 percent lower at Rs 2130.45 apiece.
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