www.fdanews.com/articles/195362-washington-devicemaker-cited-for-lack-of-sop-approvals
Washington Devicemaker Cited for Lack of SOP Approvals
January 3, 2020
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.