Mold Troubles at Sanofi Pasteur’s Toronto Plant Prompt Shutdown

Sanofi Pasteur has suspended production at its Toronto, Canada, plant to address mold troubles that recently landed the drugmaker an FDA Form 483 and prompted global shortages of a tuberculosis (TB) vaccine and a bladder cancer treatment produced there, the company says.

The French-owned company plans to renovate the facility and hire a third-party consultant to help test product batches once production lines power up again — a process expected to extend well into 2013, Sanofi Pasteur Canada spokeswoman Nancy Simpson said.

As a result of the shutdown, the plant’s two Bacillus Calmette-Guerin-based products, which include the bladder cancer treatment ImmuCyst, will be in short supply. Sanofi is working with Health Canada on testing previously shipped and quarantined lots of ImmuCyst to determine if they are safe for use, Simpson said.

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