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

By Dan Stanton contact

- Last updated on GMT

GettyImages/FotoMak
GettyImages/FotoMak

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.

Related topics: Processing

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