Issues two observations under Form 483
Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) inspected the Company's wholly owned subsidiary, APL Health Care Limited's Unit I & III, an Orals (Tablets, Capsules and Soft gel Capsules) and Derma Manufacturing facility located at Jadcherla, Mahabub Nagar District, Telangana, from 09 January to 18 January 2023.At the end of the inspection, the company has been issued a 'Form 483' with 2 observations. The observations are procedural in nature. The company will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
You’ve hit your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Quarterly Starter
₹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
Access to Exclusive Premium Stories Online
Over 30 behind the paywall stories daily, handpicked by our editors for subscribers
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