Drug firm Ipca Laboratories on Saturday said the US Food and Drug Administration (FDA) has conducted an inspection of its formulations manufacturing unit in Silvassa and issued three observations.
In a regulatory filing to BSE, Ipca Laboratories said the USFDA had conducted the inspection of the its formulations manufacturing unit situated at Piparia (Silvassa) from August 19 - 23.
"At the conclusion of the inspection, the US FDA issued a Form 483 with 3 (three) observations. The company shall be submitting its comprehensive response on these observations to the US FDA within the stipulated time frame," it added.
The company said it is committed to address these observations promptly.
The US health regulator issues observations by means of Form 483 notifying the company's management of objectionable conditions at the facility inspected.
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