Drug firm Alkem Laboratories on Tuesday said the US health regulator has issued an establishment inspection report (EIR) for its St Louis facility in the US.
The United States Food and Drug Administration (USFDA) has issued an EIR for the St Louis plant and the inspection has now been closed by the regulator,Alkem Laboratories said in a filing to the BSE.
The inspection was conducted by the USFDA from January 27, 2020 to February 6, 2020, it had said in an earlier filing.
At the end of the inspection, the company had received Form 483 with three observations and had said it shall submit to the USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.
Shares of Alkem Laboratories were trading at Rs2,576.60 per scrip on the BSE, down 0.88 per cent from the previous close.
Disclaimer: No Business Standard Journalist was involved in creation of this content
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Smart Quarterly
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app