The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs.
The Aug. 11 warning letter, requests initial certifications from the consultant and from Spacelab’s CEO by Jan. 4, and any subsequent certifications for updated audits by Aug. 4, 2015, and Aug. 4, 2016.
During the Feb. 12 to April 2 inspection of the company’s Snoqualmie, Wash., facility, the FDA found that several CAPAs were closed without implementing the corrective actions. One CAPA was opened after units were released, despite a “stop ship” command that should have prevented their distribution. The CAPA was closed and documented as effective, “even though your firm did not make changes to the stop/ship purge process to prevent the issue from reoccurring,” the letter says.
The inspection also revealed that Spacelabs accepted out-of-specification components for Qube docking station enclosures without opening a nonconforming material report, as required by its procedure. The devicemaker also failed to perform receiving acceptance activities for supplied lead wires to verify that they met a specified requirement.
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