FDA Warns Korea’s Dexcowin for Midbranding

The FDA was not impressed with Korean devicemaker Dexcowin’s responses to a Form 483 it received following an August 2017 inspection of its facility in Seoul. The agency received two responses from the manufacturer of portable dental X-rays, but then issued a 13-item warning letter.

The company’s devices were deemed to be misbranded because the Korean devicemaker failed or refused to furnish material or information on medical device reporting, and it had not established records of the results of tests for electronic product radiation safety.

The firm also failed to immediately report accidental radiation occurrences in at least two instances. The warning letter noted that the two incidents still had not been reported.

“Due to an influx of battery complaints, your firm switched battery suppliers. However, your firm did not process this corrective action through its CAPA system,” the FDA said. The agency said the firm’s response that it would include all 2017 CAPAs in an upcoming review was insufficient because a retrospective review was warranted.

Device validation procedures didn’t include predefined methods, operating conditions or acceptance criteria to ensure the device conformed to user needs and intended uses, the FDA said. 

The inspection revealed inadequate procedures for identifying, documenting, validating and verifying design changes before they’re implemented. The agency said the firm’s response did not measure up because it failed to include a retrospective review of other design changes to ensure they were appropriately validated and verified.

The firm had no documentation that testing equipment was qualified for its intended purpose, and it had not maintained device history records.