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Alembic Indian plant hit with US FDA Form 483 and four observations

Dan Stanton

By Dan Stanton+

Last updated on 19-Apr-2016 at 14:22 GMT2016-04-19T14:22:48Z

Image: iStock/CharlieAJA
Image: iStock/CharlieAJA

The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.

The facility in Panelav, Halol, was inspected by the US Food and Drug Administration (FDA) between 21 and 25 March and in a letter filed with the Bombay Stock Exchange yesterday, Alembic said it received a Form 483.

“The Company had received four observations which are being addressed by our regulatory and quality team,” company secretary Ajay Kumar Desai wrote

“We wish to inform you that to the best of our knowledge and understanding the above events or informations [sic] may not have any bearing on the operations / performance of the Company.”

The facility is one of four FDA-approved manufacturing facilities owned by Alembic, but the only one that makes finished formulations for US export, rather than active pharmaceutical ingredients (APIs).

According to the firm’s annual report , the site was last inspected by the FDA in fiscal year 2014-15 resulting in a “Zero 483.”

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