Infopia Co., Ltd. – FDA Warning Letter, Feb 20, 2014

On July 10, 2014, the FDA issued a Warning Letter to Infopia Co., Ltd. following an inspection from February 17-20, 2014, in Anyang-si, South Korea. The inspection found that Infopia's devices, including Easygluco, Element, GluNEO, GluNEO Lite, Healthpro, Hemocue HbA1c 501, LipidPro, and LipidPlus, were adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. This was due to non-conformity with the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Failure to verify or validate corrective and preventive actions (CAPA) effectiveness (21 CFR 820.100(a))**: Infopia failed to document verification or validation for two CAPAs (CA-ETC-2010-06-02 and CA-CC-2011-06-01) related to mislabeled control solutions, which led to product field corrections. The firm's revised CAPA procedure was also found to lack clear detail. Infopia's response was inadequate as it did not provide a plan to verify/validate the specific CAPAs or a retrospective review of other CAPAs. 2. **Failure to validate processes where