New Delhi : Drug firm Indoco Remedies said it has received a warning letter from the US health regulator USFDA for its Goa plant.
The United States Food and Drug Administration (USFDA) had inspected the company’s drug manufacturing facility in Goa from August 31, 2016 to September 4, 2016. As an outcome of this inspection, the facility received 6 observations in Form 483, which do not pertain to data integrity, Indoco Remedies said in a filing to BSE.
Based on the review of compliance response, the FDA accepted our response to 4 observations, it added.
“However, FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter from USFDA dated March 27, 2017,” Indoco Remedies said.
The company, however, did not share the details of the warning letter.
The company is fully committed in resolving the issue and will respond at the earliest, it added.
“The company is also committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture,” Indoco Remedies said.
The firm continues to supply products from the above mentioned facility to meet its obligations to customers and the patients in the United States of America, it added.
Shares of the company closed at Rs 249.95 apiece, down 1.21 per cent on the BSE.