Poor stability studies, inadequate complaint records and failure to document design inputs and outputs were among the quality system failures discovered during an FDA inspection of Modern Medical Equipment Manufacturing’s Guangdong, China facility.
The agency’s investigators found that stability studies covering the disposable general electrode didn’t cover all environmental conditions listed in the product labeling, and didn’t provide a justification for not verifying the functionality of the device for the full range of conditions listed on the label. For example, testing records didn’t include humidity conditions, the agency said.
The company also failed to investigate a customer complaint about a malfunctioning device that came in contact with a patient’s face and “generated burn risks,” the Form 483 said, noting that the company didn’t follow up with the patient to determine if a medical device report should be submitted to the agency.
Corrective and preventive action records were also found to be inadequate in that CAPAs opened during an FDA inspection in July 2018 were not addressed.