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Smith & Nephew plc (SNN) Responds to FDA's Warning Letter, Sees No Impact



12/29/2010 8:15:57 AM

LONDON, Dec 29 (Reuters) - Replacement joint maker Smith & Nephew (SN.L) said on Wednesday the supply of one of its hip devices would not be affected by U.S. regulator concerns over manufacturing procedures at its facility in Tuttlingen, Germany. The U.S. Food and Drug Administration (FDA) said in a letter dated Dec. 21 that certain required tests were not performed and the company had failed to establish and maintain procedures to correct problems, identified in July, in the manufacture of the R3 Ceramic Acetabular Systems.

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