Ranbaxy Laboratories' wholly-owned US subsidiary Ohm Laboratories has received a warning letter from the Food and Drug Administration (USFDA).
The drug regulator has pointed out violations of guidelines for Ohm's liquid manufacturing facility located in Gloversville, New York.
The letter was sent on December 21, 2009 and the site inspection was conducted between July and August this year.
In a notification to the Bombay Stock Exchange (BSE), Ranbaxy clarified that it is taking help of PRTM, a consulting firm, to provide expertise and advice on issues cited by the FDA.
The company also said that there were no material deviations in the other two manufacturing plants of Ohm Labs when FDA inspected them earlier this year.
"The company will continue to cooperate with the USFDA to bring the matter to closure in a timely manner and remains committed in its efforts of being fully compliant with the US regulatory standards," the notifications stated.
Ohm Labs is engaged in the sale and distribution of generic and branded private label and also over-the-counter products in the US.
The company shares closed at Rs 520.05, down 1.55 per cent on the BSE today.
