The company will respond to these observations within the stipulated time of 15 days
Company sources inform none of the observations are critical and are related to areas of improvement in documentation and review procedures
The US Food and Drug Administration (US FDA) audit, which started on January 17, 2019 at Indoco’s Goa Plant I (Oral Dosages Facility), concluded on January 25, 2019 with the Regulatory Agency issuing six observations (483s) to the site. None of these observations are critical in nature.
The company will respond to these observations within the stipulated time of 15 days.
Aditi Kare Panandikar, Managing Director, Indoco Remedies commented, “Most of these observations are related to areas of improvement needed in documentation and review procedures. These observations / recommendations will help us further improve our quality systems in the plant, which in turn, will give a boost to revenues from the US market.”
The site will continue to supply to the US market, the existing approved product and await approval of pending ANDAs.