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Home » Washington Devicemaker Cited for Lack of SOP Approvals
Washington Devicemaker Cited for Lack of SOP Approvals
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The FDA came down on Black Diamond, Washington device manufacturer G. Dundas for lacking signatures of approval on its standard operating procedures.
G. Dundas, a manufacturer of waste gas scavengers (used in hospitals to collect gas that is exhaled by a patient), was hit with a Form 483 because a number of its SOPs lacked approval signatures.
Specifically, a document control, engineering change order, self-audit and equipment calibration SOP all needed signatures of approvals.
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