USV receives FDA close-out at Indian plant
USV received a warning letter from the US Food and Drug Administration (FDA) last March, following an inspection at its facility in Dabhel, Daman in 2016.
In the letter, the FDA said USV’s “oversight and control over the manufacture of drugs is inadequate,” citing problems over how the firm tested for microbial contamination at the site.
But now the Agency has given the facility the all clear in a close-out letter sent to USV last week.
“Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.”
According to USV, the Daman facility manufactures tablets, capsules and coated tablets and has certification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Finnish Medicines Agency (Fimea), on top of the FDA.
The plant has 2,150 tonnes of granulation capacity and can produce 3.3bn tablets and 578m capsules.
