FDA Hits Georgia Devicemaker for CAPAs
The FDA hit Scientific Intake of Gainesville, Georgia with a Form 483 for its handling of corrective and preventive actions.
During an April 9-11 inspection, the agency took issue with the way the firm documented multiple CAPAs. For example, one for a “possible allergic reaction” by a patient had no documentation of the root cause, remedial action or required CAPA action.
Another CAPA related to “difficulty breathing when wearing device” was deemed a “device fit issue” and had no documentation for remedial action, the investigator found.