Novartis’ Quality Control Unit Warned

The FDA takes issue with one of Novartis’ manufacturing facilities in a Jan. 24 warning letter citing the unit’s production and process controls for its human rabies vaccine RabAvert and bulk ingredient for diphtheria and tetanus toxoid concentrate, used in GlaxoSmithKline’s (GSK) combination vaccines Infanrix and Pediarix.

“The warning letter is specific to validation gaps isolated to select manufacturing and control aspects, and the company is aggressively pursuing improvements which will assure closure of these gaps,” Novartis said. The agency’s issues are being quickly resolved, and an updated manufacturing process for rabies vaccine production was submitted to regulatory authorities in December 2007. All distributed vaccines met regulatory specifications, the company added.

Novartis responded in October and November 2007 to the FDA’s original Form 483 inspectional observations, issued to the company’s Marburg, Germany, facility following a September 2007 inspection. In its warning letter, the agency says the firm’s “response appears to address the individual FDA Form 483 items. However, we note that your response addresses these issues individually and not as part of a comprehensive corrective action plan.”

The warning letter cited problems in three areas: production and process controls, failure investigations and equipment cleaning and maintenance.