Alkem shares slump 5.5 pc on USFDA observations for 2 units

Shares of Alkem Laboratories today slumped 5.5 per cent after the company said the US Food and Drug Administration (USFDA) has pointed out 14 observations for objectionable conditions at its manufacturing units at Amaliya in Daman and St Louis in the US following inspections.

The company's stock plunged 5.51 per cent to end at Rs 1,977 on BSE. Intra-day, it tanked 11.26 per cent to Rs 1,856.60.

On NSE, shares of the company tumbled 5 per cent to close at Rs 1,988.35.

The USFDA had conducted an inspection at the Daman unit from March 19-27, 2018, Alkem Laboratories said in a regulatory filing.

"Post the inspection, the company has received a Form 483 with 13 observations," it added.

As per the USFDA, Form 483 notifies the company's management of objectionable conditions based on observations made by its investigators about conditions or practices which would "indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health".

The company further said that the USFDA had conducted an inspection at its manufacturing facility located at St Louis, USA from March 12-16, 2018.

In response to one Form 483 observation issued by the USFDA, it has submitted a detailed corrective and preventive action plan to the regulator within the stipulated timeline, Alkem said.