FDAnews Device Daily Bulletin

‘Grandfathered’ Suppliers Cited in Westone Warning Letter

Nov. 30, 2012
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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