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

By Dan Stanton

- Last updated on GMT

Image: iStock/CharlieAJA
Image: iStock/CharlieAJA

Related tags Food and drug administration

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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