FDA Warns Novartis about CGMP Violations

Rockville, MD (Jan. 30)-The US Food and Drug Administration posted on its website a Jan. 24 Warning Letter to Novartis Vaccines and Diagnostics (Cambridge, MA). The agency cited Novartis’s Marburg, Germany, facility for deviations from current good manufacturing practices, including faulty production and process controls, incomplete failure investigations, and unvalidated cleaning procedures.

The letter noted that a particular lot of Novartis’s “RabAvert” rabies vaccine was processed and submitted to FDA even though its sterility could not be ensured. An investigation showed that two lots of RabAvert were contaminated with Candida guilliermondii during the aseptic filling of a particular media lot. FDA noted, however, that the facility did not perform sterility testing on 15 other lots exposed to the contaminated media lot.

Also, a failure investigation closed in January 2006 showed that six lots intended for rabies vaccine were contaminated. Four were linked to contaminated media. Novartis did not implement final correction until January 2007, according to the letter. During the elapsed time, two contaminated media lots were found and two RabAvert vaccine lots were linked to a contaminated media lot.

Finally, FDA stated that cleaning procedures at the facility were modified without being validated. The agency observed that Novartis did not conduct studies to determine the changes’ effect on the cleaning processes.

FDA inspected the Marburg facility Sept. 20–27, 2007. The agency subsequently sent Novartis a Warning Letter, to which the company responded in letters dated Oct. 12, 2007 and Nov. 9, 2007. FDA acknowledged that Novartis’s responses addressed the original violations, but added, “your response addresses these issues individually and not as part of a comprehensive corrective action plan.”