FDAnews Device Daily Bulletin

‘Grandfathered’ Suppliers Cited in Westone Warning Letter

Nov. 30, 2012
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Westone Laboratories’ failure to set supplier controls for companies it “grandfathered in” has landed it an FDA warning letter. The devicemaker, which makes Oto-Ease patient lubricant, did not establish quality requirements for either the suppliers of bulk lubricant or the contract manufacturers of containers.
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