Improper Label Disposal Leads to Warning Letter

The FDA has warned ChungDo Pharma, a South Korean maker of urinalysis test strips, for destroying incorrect labels without proper documentation. The company’s nonconforming report identified certain labels as mislabeled, and the company said they were destroyed. But ChungDo “failed to properly document the method of destruction, the place and date of the destruction, the person conducting the destruction and the destroyed quantity,” according to the warning letter.
Devices & Diagnostics Letter