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BRIEF-Indoco Remedies gets form 483 from USFDA for inspection at Goa facility
March 31, 2017 / 11:47 AM / 8 months ago

BRIEF-Indoco Remedies gets form 483 from USFDA for inspection at Goa facility

March 31 (Reuters) - Indoco Remedies Ltd:

* Says USFDA had inspected drug manufacturing facility at Verna, Goa, from August 31st 2016 to September 4th, 2016

* Says as an outcome of inspection, facility received 6 observations in form 483, which do not pertain to data integrity

* Says continue to supply products from facility

* Says based on the review of compliance response, FDA accepted co’s response to 4 observations

* FDA remains concerned with respect to 2 observations, pertaining to one specific product, for which co is contract manufacturer

* Received a warning letter from USFDA dated 27th March 2017 Source text:

The USFDAhad inspected our drug manufacturing facility (Plant II & Plant III, L-32,33,34 Verna Industrial Estate Area, Verna, Goa) , from August 31st 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 27thMarch 2017, today. Further company coverage:

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