Bard Interventional biopsy forcep labeling mix-up cited in warning letter.
This article was originally published in The Gray Sheet
BARD INTERVENTIONAL BIOPSY FORCEP LABELING MIX-UP resulted from a failure to follow written operating procedures, FDA charges in a July 6 warning letter to Bard. The company failed to follow a procedure "for packaging inspection [of] disposable biopsy forceps" which states that there should be verification of "`of packaging components per material routing/shop order,'" FDA says.
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