FDA WARNING_LETTER - KooJoo Trading Company - April 25, 2013

On April 22-25, 2013, an FDA inspection of KooJoo Trading Company in Gimpo-City, South Korea, revealed that their manufactured lancets and lancing devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Production Process Control (21 CFR 820.70(a))**: The contract sterilizer's dose range for GP Lancets and Safety Lancets (b)(4) to (b)(4) did not meet the firm's validated range of (b)(4) to (b)(4). At least (b)(4) lots were released with incorrect sterilization. The firm's proposed revalidation is inadequate as it doesn't address distributed non-conforming product. Additionally, dose audits were not performed per the established schedule (every (b)(4) for (b)(4), then (b)(4) for (b)(4), then (b)(4) from (b)(4) on). 2. **Process Validation (21 CFR 820.75(a))**: The (b)(4) process for GP Lancets and Safety Lancets was not validated. 3. **Corrective and Preventive Action (CAPA