FDA Slaps Novartis With Warning For Cleaning Violations, Improper Procedures

By Lori Clapper, Editor

The FDA cited three Novartis generic pharmaceutical plants for "significant violations of Current Good Manufacturing Practices (cGMPs)," according to its November 18 warning letter. Regulators inspected Novartis' Sandoz facilities in Colorado, North Carolina, and Quebec between May and August 2011. They observed inadequate cleaning and written procedures that affect the sterility and composition of the drugs manufactured in those plants.

Inspectors found crystals in vials of an injectable liquid drug at the Quebec plant, according to a Reuters report. In its letter, the FDA wrote the company lacked process consistency in the manufacture of the particular injectable. This and two other violations were repeat offenses addressed in a 2008 warning letter.

The FDA also notified Novartis that: "Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer."

According to Marketwatch, Novartis and Sandoz said they are working with the FDA to solve the problems to ensure there will be no drug shortages.