Alkem Laboratories shares fell over five per cent to an intraday low of Rs 1,586.05 on Monday, after the pharma company said it received observations from the US Food and Drug Administration (USFDA) following inspection of its active pharmaceutical ingredients facility in Ankleshwar, Gujarat.
The Mumbai-based pharmaceuticals company said the US health regulator had conducted an inspection at the Ankleshwar facility from December 5 to December 9. The inspection report contains 483 observations, it added.
"The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA Observations and the same is proposed to be filed within the timeline stipulated by US FDA," it said in a regulatory filing.
The US drug regulator issues Form 483 to a company's management at the conclusion of an inspection when investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
At 1:50 p.m., 23,066 shares exchanged hands against its two-week average of 4,039. Shares were trading 3.39 per cent lower at Rs 1,618.50 apiece on the BSE, whose benchmark Sensex index was down 0.62 per cent.