Teva has emerged from the dark side of a voluntary plant shutdown tied to GMP violations, restarting production at its Irvine, CA, facility. The plant is the former production home of propofol, the anesthetic made famous in the wake of Michael Jackson's death. Teva dropped the product from its portfolio last summer for business reasons.
According to Dow Jones, the generics maker says ramp-up will take most of this year. Teva announced 200 production and support jobs cuts this January related to the 2009 plant closure.
Propofol was the subject of a massive recall in July 2009 for suspected bacterial contamination. The recall was followed by a 12-count warning letter in December that the FDA issued after having received six Teva responses to an inspection report. Among the violations are shortcomings in raw material testing, batch failure investigations, equipment cleaning and sanitizing and recordkeeping.
Separately, Teva says it has submitted a corrective-actions response to the FDA warning letter issued in early February for an oral drug plant in Israel.
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