US FDA adds Mahendra Chemicals to import alert "Red List"

By Gareth Macdonald contact

- Last updated on GMT

Mahendra Chemicals has been banned from shipping drug ingredients made at its plant in Ahmedabad, India to the US.

The active pharmaceutical ingredient (API) manufacturer - whose products include antibiotics and lidocaine - was added to the US Food and Drug Administration’s (FDA) 66-40 import​ alert list – also known as the “Red List” – last Friday.

According to the FDA, companies are subject to an import alert when an “inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's)​.”

No further details were provided. Mahendra’s inclusion on the import alert means its products can be detained at US borders.

The firm did not respond to a request for comment.

Mahendra's last run-in with the US FDA was in July 2015​ when it received a warning letter detailing problems observed at the Ahmedabad site during an inspection in May 2014.

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