Granules hit by FDA 483 with one observation at ex-Valeant VA plant

By Dan Stanton

- Last updated on GMT


Related tags Food and drug administration Fda

The US FDA made one observation at the finished dose formulation in Chantilly, Virginia bought by Indian drugmaker Granules from Valeant Pharmaceuticals in 2014.

In a letter filed with the Bombay Stock Exchange (BSE) today, Granules India Ltd announced the US Food and Drug Administration (FDA) inspected its facility in Chantilly, Virginia last week and issued a Form 483 with one observation.

Spokesperson Sumanta Bajpayee would not comment on the issue raised by the inspectors, nor the firm’s remediation plan when contacted. However, the filing said: “Granule Pharmaceuticals, Inc. will respond to this observation within the stipulated time period,”​ which is 15 business days.

Bajpayee told in-PharmaTechnologist: “Currently only product development work is going on with no commercial production.”​ 

The facility is a finished formulation plant acquired from Valeant Pharmaceuticals in 2014. Earlier this year the Indian drugmaker said it was adding manufacturing capacity at the site through a $35m (€30m) expansion, expected to create 102 jobs.

The Virginia Economic Development Partnership, which provides consultative services and funding to companies creating jobs, backed the expansion at the site. According to Virginia Business​,​ Granules is eligible to receive $750 per job.

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