Alkem Laboratories (NSE:ALKEM, BOM:539523) said it has received Form 483 with seven observations from the U.S. Food and Drug Administration after inspection of its manufacturing facility in Daman, India, according to a Saturday filing on Indian bourses.
Shares of the company fell nearly 1% in Monday's trade.
The inspection was conducted from April 20 to May 1, the filing said.
The company said it will respond to the observations within the specified timeframe.
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