Wockhardt CEO Says 483 Issues Will Be Resolved

Wockhardt’s CEO Habil Khorakiwala has characterized the FDA’s recent findings of nine Form 483 observations at its manufacturing plant in Shendra, India as minor, and predicted that the agency’s concerns would be resolved within a few months.

While not revealing the nature of the inspections, Khorakiwala said more than half of the FDA’s questions raised in a recent 483 should be resolved within a few weeks.

During a Jan. 18 conference call, Khorakiwala said there were “extensive discussions with the FDA for a resolution” of the shortcomings, previously disclosed by the company. The FDA’s inspection was to determine whether drugs made at Shendra were fit for export to the U.S.

Khorakiwala noted that the Shendra plant, which produces sterile injectable drugs, is relatively new, and there are no supplies of products going from the factory to the U.S.

Wockhardt initiated numerous recalls last year of products manufactured at its Waluj and Chikalthana facilities due to quality concerns.

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