FDA Keeps Its Import Alert Intact on Polish API Manufacturer
March 22nd, 2012 // 1:37 pm @ jmpickett
On its modest web site, Nobilus Ent brags that active pharmaceutical ingredients are offered at a good quality for a reasonable price and that its two facilities, which are based in Poland, meet good manufacturing practices. But not according to the FDA. The agency is keeping the supplier on an import alert for one of the plants.
Nobilus, you see, has a problem with contamination, or an “unacceptably high risk,†as the agency noted, largely because of a lack of facilities that are dedicated to separate steps of the production process. For instance, a raw storage area is not separated from other activities and, consequently, personnel may be mingling different active pharmaceutical ingredients as they move them about.
Significantly, Nobilus failed to monitor or test its APIs for contamination, according to a March 7 warning letter that refers to an agency inspection conducted last fall at the Kutno facility, which is located north of Lodz. There were also problems with heating and ventilation systems (here is the warning letter). Of course, failing a follow-up inspection is never good.
“Until such time as your manufacturing practices are verified to comply with CGMP, including demonstrating that your facility has been comprehensively decontaminated, your firm will remain under FDA Import Alert, and FDA will continue to refuse admission of all articles manufactured†at the Nobilus Ent facility in Kutno into the US,†the FDA writes to the supplier.
The move, as you know, comes as the FDA attempts to get tougher on plants that make drugs and active pharmaceutical ingredients in the wake of the heparin scandal and overall concerns about the pharmaceutical supply chain. The agency, for instance, wants to tap generic user fees to boost inspection of facilities
