Indoco Remedies Limited has informed the Exchange Vide letter dated March 31, 2017 that "The USFDAhad inspected our drug manufacturing facility (Plant II & Plant III, L-32,33,34 Verna Industrial Estate Area, Verna, Goa) , from August 31, 2016 to September 4th, 2016. As an outcome of this inspection, the facility received 6 observations in Form 483, which do not pertain to data integrity. Based on the review of compliance response, FDA accepted our response to 4 observations. 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, today. We as a company are fully committed in resolving the issue and will respond at the earliest. The company is also committed to its philosophy of highest quality in manufacturing, operations, systems integrity and cGMP culture. We continue to supply products from the above mentioned facility to meet our obligations to our customers and the patients in the United States of America.".
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