Indoco Remedies receives six observations from USFDA for its Goa Plant II

07 Sep 2016 Evaluate

Indoco Remedies has received six observations from United States Food & Drug Administration (USFDA) for its Goa Plant II. USFDA had inspected the company’s Goa Plant II from August 31, 2016 to September 04, 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.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India. Indoco, a $149 million company, employs over 5500 people including 300 skilled scientists.




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