Strike Three, Yer Out! FDA Bans Drug Products from Third Wockhardt Plant in India
Attachment: india
SUGAR LAND--August 12, 2016--Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--In a situation that has gone from bad to worse, the U.S. Food and Drug Administration (FDA) has issued Indian drugmaker Wockhardt (Mumbai) an import alert against it manufacturing plant at Ankleshwar. The site, which manufactures active pharmaceutical ingredients (APIs), received a Form 483 following an unfavorable FDA inspection last year.
Within this article: Describes the regulatory actions in 2013 taken by the FDA that spurred the fall of Wockhardt.
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