Intas Pharmaceuticals, which has been under scrutiny from the U.S. FDA lately, had its manufacturing site near Ahmedabad, India, slapped with an “import alert” by the agency.
The admonishment comes just months after the FDA issued a scathing Form 483 notice that outlined a cascade of failures at a separate Intas plant in Gujarat.
In Intas’ latest regulatory interaction, the company was issued an import alert dated June 1. The alert, however, allows the company to continue to supply 24 products from the Ahmedabad site that are considered in short supply in the U.S.
The list of drugs excluded from the import alert include injectable products targeting cancer and bacterial infections plus tablets used for sedation, kidney stone diseases, hormonal complications and heart issues, according to agency’s letter.
Intas did not immediately respond to Fierce Pharma's request for comment. In a statement to Hindu Businessline, the company said that after it received FDA observations relating to the Ahmedabad site last year, it made the "immediate and voluntary decision to temporarily cease the manufacturing and distribution of products" made there and destined for the U.S.
The company is working to address the FDA's concerns, Intas told Businessline.
In the case of the company’s Gujarat facility, an inspection conducted by the FDA late last year uncovered a laundry list of production problems despite certain employees’ alleged efforts to obscure the truth. In one instance, inspectors found shredded documents covered in acid. That inspection resulted in 11 observations.