FDA WARNING_LETTER - APK Technology Co., Ltd. - February 03, 2015

On August 6, 2015, the FDA issued a Warning Letter to APK Technology Co., Ltd. following an inspection from January 26 to February 3, 2015. The inspection revealed that the firm's blood pressure cuffs and oximeters are adulterated under 21 U.S.C. § 351(h) because manufacturing processes do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Lack of documented validation for oximeter component manufacturing processes. The firm's response, detailing updated procedures and planned validations, lacked documentation of corrective actions. 2. **Design History File (DHF) (21 CFR 820.30(j)):** Absence of DHFs for 91 of 108 oximeter models and 42 blood pressure cuff models distributed in the U.S. since 2007/2008. The firm's response, outlining new procedures for family-specific DHFs, lacked documentation. 3. **Equipment Requirements (21 CFR 820.70(g)):** No documentation for appropriate installation of oximeter manufacturing machines. The firm's response, detailing updated procedures and planned Installation Qualification reports, lacked documentation. 4.