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Indoco Remedies gets issued six 483 observations for its Goa Plant II

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From USFDA

Indoco Remedies announced that USFDA inspected the Company's Goa Plant II from 31 August 2016 to 04 September 2016. The injectable ANDA filings triggered this inspection.

At the end of the inspection, six 483s were issued. All the observations(483s) are correctable and the Company expects to complete the corrective and preventive actions within a period of 30 days.

None of the 483s are related to Data Integrity issue.

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First Published: Sep 07 2016 | 3:02 PM IST

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