Indoco Remedies has said that the USFDA inspected its sterile facility (Plant II) and solid dosages facility (Plant III) situated at Verna Industrial Estate, Goa, from 14-21 November, 2018. The inspection has concluded with Indoco receiving two minor observations.
The company has said that none of these are repeat observations. However, it has termed this inspection to have cleared both the facilities, which is a positive development for both the plants.
This facility had received a Warning Letter from the USFDA in March 2017.
The company has said that it is in the process of responding to the USFDA observations within the stipulated time of 15 days. It has also said that it would be able to get an EIR subsequently. This will pave way for getting approvals to its pending ANDAs and boost Indoco’s revenues.
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