New Delhi: Drug firm Wockhardt said the US health regulator has made “observations” in its Establishment Inspection Report (EIR) for the company’s three units in Maharashtra and ban on exports from the facilities to the US will continue.
The company’s three facilities – Chikalthana and two units at Waluj in Maharashtra – have received EIR with observations, Wockhardt said in a regulatory filing.
“However, receipt of EIR does not change our existing status for the concerned units. Receipts of EIR does not materially change the status of import alert for the concerned manufacturing units for the US market,” the Mumbai-based company added.
EIR is given to an establishment after the completion of the inspection by the US Food and Drug Administration (USFDA).
The company’s Waluj plant was hit by an import alert by the USFDA in 2013 for not meeting manufacturing norms. The facility produces injectables as well as solid dosages.
The Chikalthana facility was also put under import alert by the USFDA on the issue of non-compliance of manufacturing norms.