Cleaning procedures at Getinge's N.J. plant trigger FDA warning

08/25/2010 | Clinica (subscription required)

The FDA issued a warning letter to Getinge regarding issues with its vascular graft cleaning procedures at its production plant in Wayne, N.J., and a discrepancy related to the 2006 recall of the Hemashield vascular graft. Getinge CEO Johan Malmquist said the warning would not affect the production and marketing of its products at the facility, and that the company hopes to resolve the issues by the end of the year.

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