The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations.
US FDA conducted an inspection of Alkem’s API manufacturing facility located at Ankleshwar from 5 to 9 December.
Drug firm Alkem Laboratories on Monday said that the US health regulator has issued three observations after inspection of the company’s Active Pharmaceutical Ingredient (API) facility at Ankleshwar in Gujarat.
“United States Food and Drug Administration (US FDA) had conducted an inspection at the company’s API manufacturing facility located at Ankleshwar from 5 December to 9 December, 2016,” Alkem Laboratories said in a filing to BSE.
The company has received the inspection report which contains three Form 483 observations, it added.
The company shall put together a detailed response with adequate corrective and preventive measures to address the USFDA observations and the same is proposed to be filed within the time line stipulated by the US health regulator, Alkem Laboratories said.
According to USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company’s management of objectionable conditions.
Shares of Alkem Laboratories were on Monday trading at Rs1,610 in the afternoon trade on BSE, down 3.90% from its previous close.