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Six observations issued by USFDA to Indoco’s Goa Plant on account of violation of good manufacturing norms

Goa’s Indoco Remedies plant was inspected by USFDA from August 31, 2016 to September 4, 2016. On account of inspection, USFDA has issued six observations due to violation of good manufacturing norms. The injectable abbreviated new drug application (ANDA) filings triggered this inspection.

Six 483s have been issued and all the observations listed in the 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.

As per the FDA, "an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts."


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