Cephazone Pharma received the warning letter in April 2011 after US Food and Drug Administration (FDA) inspectors found fault with procedures to stop microbiological contamination at the plant. In November inspectors revisited the facility in Pomona, California and have now sent a closeout letter.
“It appears that you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections,” Alonza Cruse, FDA director, Los Angeles district, wrote in the closeout to Cephazone.
As well as the November inspection the FDA also reviewed written responses Cephazone sent after being hit with the warning letter. In combination these have reassured the FDA that the production plant is now compliant with cGMPs (current good manufacturing practices).
Failings found during the initial inspection included a lack of validated written procedures for the environmental monitoring and disinfection. The violation related to the use of reconstituted beta-lactamase to neutralise cephalosporins in the Tryptic Soy Broth used in media fills.
“You have not demonstrated the ability of the neutralizing agents in the surface sampling plates purchased by your firm to neutralise the cephalosporin drug products manufactured at your firm,” the FDA inspectors wrote in last year’s warning letter.
Cephazone was also criticised for giving all employees access to the computer system that monitors equipment, room differential pressure, room humidity and stability chambers. Although the system was password protected, the room housing the computer – and the hard drive - were unlocked.
“During the inspection we observed that an employee was able to alter or delete data without a password and save the changed file,” the FDA wrote. Cephazone responded to the problem after the 483 but the FDA wanted to see the firm “take a global approach to this deficiency.”