Massachusetts Devicemaker Cited for Inadequate CAPA

The FDA hit Methuen, Massachusetts device manufacturer Globus Medical with a Form 483 for a deficient corrective and preventative action.

The firm launched a CAPA to verify that its quality records were properly documented, but did not identify the specific quality system procedures it was evaluating, the agency found during a Feb. 5-13 inspection.

The CAPA was started because “there is a compliance risk due to the fact that internal related procedures...are either nonexistent, are missing required steps in the process, or are not being followed,” the agency noted.