The FDA Targets Novartis Manufacturing Plants

The FDA Targets Novartis Manufacturing Plants

December 8th, 2011 // 3:13 pm @

If you happen to run a big drugmaker, you know the FDA has its eye on you when a warning letter cites a host of problems at three manufacturing facilities and you are instructed to schedule a meeting within five days to discuss plans to rectify your myriad transgressions. In other words, the heat is on. And that is what the Sandoz generic unit of Novartis is now facing.

The drugmaker received a November 18 warning letter for “significant violations” at two plants in the US – Broomfield, Colorado and Wilson, North Carolina – and another in Boucherville, Quebec, in Canada. And several of the many infractions were actually repeat offenses. The upshot is that the FDA, which is trying to get tough on manufacturing issues, is examining Sandoz for systemic problems. To underscore the matter, the letter was sent to Novartis ceo Joe Jimenez in Switzerland.

The warning letter (which you can read here) cites a long list of mishaps at the plants, each of which were inspected over several days earlier this year. Among the various problems: a failure to submit NDA field reports; a lack of written procedures to prevent microbiological contamination; a failure to clean equipment at the appropriate intervals and crystals found in vials of some injectable drugs.

Generally, the FDA will instruct a drugmaker to respond in writing within 15 days of receiving the warning letter by outlining specific steps that have been taken to correct violations. However, the agency does not normally add that the Office of Manufacturing and Product Quality must be contacted with five days to schedule a meeting to discuss proposed corrective actions.

In this case, however, the FDA made a point of writing to Jiminez that there is a great deal of interest in learning his plan for “ensuring timely and meaningful involvement of corporate senior executive management from Novartis, Sandoz Inc., and Sandoz Canada Inc. in addressing significant issues in the future.” At least one 483 inspection report has been issued. It appears Joe should expect more.

[UPDATE: In a note to Novartis employees today, Jimenez writes: “This is disappointing, but we are moving quickly to address broadly the issues in a sustainable way. I will personally be involved in monitoring the progress of the remediation. I want to make it clear that neither costs, nor service level will interfere, as the remediation needs to take place as quickly as humanly possible” (you can read the entire memo here).]

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