OR WAIT 15 SECS
Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices.
Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of its rabies vaccine (RabAvert) and diphtheria and tetanus toxoids adsorbed concentrate (without preservative), with regard to bulk lot production and process controls and investigations.
The nonconformities include deviations from the applicable requirements of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, as well as requirements of Novartis’s biologics license application approved under section 351(a) of the Public Health Service Act and 21 CFR Part 601.
The letter describes the results of an FDA inspection that was conducted at the company’s site in Marburg, Germany, between September 20 and September 27, 2007. Some of the key deviations cited include:
Other deviations cited in the warning letter were related to incomplete investigations of sterility failures and failures to validate changes in cleaning procedures. The letter advised the company that the failure to implement effective corrective actions and preventive measures might result in the FDA taking regulatory action without further notice.