Indoco’s Goa Plant I receives Warning Letter from US FDA

Indoco Remedies has received a Warning Letter from The United States Food and Drug Administration for its Oral dosages Plant, situated at L -14, Verna Industrial Road, Goa, after an inspection which was carried out in January 2019.

The facility had received six observations in Form 483s and was classified as ‘OAI’ (Official Action Indicated) in March 2019. The Company responded to these observations with a detailed remediation plan, the implementation of which is still on-going.

Commenting on the development, Aditi Kare Panandikar, Managing Director, said that "We have already done considerable remediation work and shall continue to implement necessary additional corrective actions. We are committed to being cGMP compliant and supplying quality products to our customers and the patients across the globe."

The company also stated that it will respond to the Warning Letter within the stipulated time and is already working with cGMP consultant to ensure that the remediation activities are completed in line with the US FDA’s expectations.

The Company has one approved ANDA from this site, the annual revenue of which is around
Rs 3 crore. There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved.

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