Italian Medicines Agency Cites Indian API Facility Over GMP Non-Compliance

The Italian Medicines Agency cited Indian API manufacturer Kores for data integrity and systems security issues.

Following a March inspection of the company’s Roha facility, the agency issued a GMP non-compliance report listing numerous deficiencies, including compromised analytical data.

The inspection focused on one API, ambroxol hydrochloride. The agency called for a recall provided it would not lead to a market shortage of the decongestant. Ambroxol hydrochloride is not currently marketed in the U.S. but is widely sold elsewhere.

The inspectors also faulted the facility’s quality control, computer security and out-of-specification management.

The agency said the deficiencies found in the inspection could affect other APIs manufactured at the facility.