Berlex warning letter
FDA warning letter for Berlex' Quinaglute Dura-Tabs says firm's quality unit "failed to prevent the release of six lots" of Quinaglute that "contained visible metal fragments which came from unqualified manufacturing equipment." The filed product spec "does not include visible metal fragments," FDA said. Berlex contends its investigation did not present "confirmatory evidence" that any tablets containing metal fragments were manufactured at its Wayne, N.J., plant. The company says it responded to FDA's March 11 letter and that there have been no Quinaglute recalls...
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
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