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.