Sanofi Hit with FDA Warning Letter for Conditions at Vaccine Plant

Sanofi Pasteur R&D Centre, Canada

Drug maker, Sanofi, was just sent a lengthy U.S. Food & Drug Administration (FDA) warning letter detailing dozens of observations at the Sanofi Pasteur plant located in Canada.

The letter, said FiercePharmaManufacturing, discussed mold and contamination issues that led to the closure of some of Sanofi’s operations. The closures, say the drug maker, will lead to shortages of its BCG tuberculosis vaccine.

Sanofi Pasteur, described by FiercePharmaManufacturing as the world’s largest manufacturer of human vaccines, recalled four batches of its tuberculosis vaccine BCG last month. At the same time, Sanofi suspended production at a Canadian plant following discovery by Australian regulators of sterility problems.

Shortages in Australia and, likely, Canada, are expected, noted FiercePharmaManufacturing. The halt in production could also lead to a worldwide shortage of ImmuCyst, a bladder cancer drug. In response, Len Lavenda, Sanofi spokesman, said, “As of today, this notification does not impact our ability to supply the market, except for our BCG products manufactured in Toronto.”

The FDA warning letter is posted on its website and details a rather long list of observations: 24 at its Toronto plant, which was inspected in April, as a couple found during a routine March inspection of its Marcy l’Etoile plant in France. According to the FDA, the Toronto inspection revealed that, “there have been no less than 58 documented non-conformances relating to the isolation of mold within the BCG aseptic processing areas” since August 2010, according to FiercePharmaManufacturing.

Sanofi told FiercePharmaManufacturing, it is working as quickly as possible to handle both plants’ issues the agency raised and has advised the FDA about what actions it has taken, so far. Sanofi said it has “full confidence in the products released from its facilities” and that the manufacture of safe and efficacious vaccinations and biological products “remains Sanofi Pasteur’s highest priority.” Olivier Charmeil, president and CEO, Sanofi Pasteur said, “Sanofi Pasteur takes the observations outlined in the recent FDA Warning Letter seriously…. We are working diligently with the FDA to implement a series of immediate and ongoing steps to address their concerns and further strengthen our global manufacturing operations and quality systems. I have full confidence in our products in the market,” wrote FiercePharmaManufacturing.

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The FDA does not appear to agree, saying in its letter that, because of testing issues, Sanofi can not be certain that all of its lots of the BCG vaccine that were produced in one Sanofi building since its last successful sterility test, are safe. That test, said FiercePharmaManufacturing, took place in 2000. Also, the agency said questions exist concerning Sanofi’s ability to detect mold.

FDA investigators also discussed problems with how vials were handled in the aseptic processing area in Sanofi’s filling and packaging building; Sanofi employees were allowed, “unchallenged,” from the live vaccine area to the washing and sterilizing area, raising questions about disinfection practices. The agency also said it observed “nesting birds” in the air handling units during its April 18 investigation, said FiercePharmaManuacturing. The letter also discussed problems in France regarding inadequate investigations over some lots of its Conjugated Haemophilus Vaccine and typhoid vaccines, all of which tested out of specifications.

Sanofi has been ordered to conduct a “comprehensive and global assessment of all of its manufacturing operations to ensure that all products conform to FDA requirements.” The FDA suggested the drug maker’s New York officials meet with the agency to discuss responses and plans, noting that warning letters concerning biological products “are passed along to federal agencies” to ensure the information is considered when reviewing contract awards.

Among the issues, were specific plant problems, problems with the organization and its personnel, and problems with buildings and facilities; production, processing, microbiological, and laboratory control issues; batch production and control record problems; and failure investigations. The letter, which details the extensive list of issues at the Sanofi plants, can be accessed here.