Sun Pharmaceutical Industries share price fell nearly 3 percent intraday Friday after CNBC-TV18 reports quoting agencies that the company has received 11 observations from the US health regulator for its Dadra unit.
While inspecting the plant, the US Food & Drug Administration found incomplete lab records at the pharma major's Dadra plant.
These observations include failure to produce appropriate master or control record for each batch of drugs and failure to properly investigate batches that don't meet specifications.
Inspection of the plant by USFDA was concluded in the first week of this month.
Dadra site is the biggest unit for the compay after Halol plant, for supplying drug in the United States.
Analysts say with these observations, the problem for the company may aggravate as its Halol plant has already been under import alert, which contributed 40 percent to US sales in FY16.
Meanwhile, in the first week of current month, the US Food & Drug Administration had said it would lift the import alert imposed on Mohali (Punjab) manufacturing facility and would also remove the facility from official action initiated (OAI) status.
Mohali, which had been under import alert since September 2013, is an oral solids plant and capacity-wise is understood to be as big as Ranbaxy's Ohm Labs facility in the US.
At 09:38 hours IST, the stock was quoting at Rs 643.35, down Rs 12.50, or 1.91 percent on the BSE.Posted by Sunil Shankar Matkar