Indian drugmaker Cadila Healthcare said it received an Establishment Inspection Report (EIR) from the FDA for its facility in Ahmedabad.
An EIR is issued when the FDA has closed out its inspection of a facility. In this case, the inspection of the Ahmedabad oral solid dosage drug manufacturing plant was conducted in January. Though EIRs are somewhat routine, what made Cadila’s announcement in a filing to the Bombay Stock Exchange stand out was the disclaimer that came at the end of the statement reported by The Economic Times.
"The receipt of EIR indicates the successful closure of the inspection points raised,” the company said, adding that “it may be mentioned that this plant is a separate manufacturing unit and does not form a part of the Moraiya formulations manufacturing facility.”
The Moraiya plant, which is a formulation site, was one of two Cadila plants in Gujarat to get warning letters the same month as the inspection of the Ahmedabad facility.
In those warning letters by the U.S. regulatory agency, inspectors said they had serious concerns about Cadila's production of warfarin products following inspections in 2014. According to the agency, at least 5 batches fell short of expectations, but the drugmaker never uncovered the root cause so that it could be fixed.
It’s unclear at this time why Cadila felt the need to mention the "separateness" of the Ahmedabad and Moraiya facilities.
- check out The Economic Times story
Related Articles:
FDA warning letter tells Cadila to resolve problems with warfarin production
Cadila recalls tens of thousands of bottles of antidepressant
Editor's note: This story previously included a picture of Cadila Pharmaceuticals, which is not associated with Cadila Healthcare.