FDA WARNING_LETTER - A & D Electronics (Shenzhen) Co., Ltd. - August 09, 2012

On November 13, 2012, the FDA issued a Warning Letter to A&D Electronics (Shenzhen) Co., Ltd. following an inspection from August 6-9, 2012. The inspection found that the firm's non-invasive blood pressure monitors, bathroom scales, nebulizers, and digital thermometers were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain procedures for analyzing quality data to identify nonconforming product causes and employ statistical methodology (21 CFR 820.100(a)(1)). The firm's CAPA procedure was inadequate, with multiple 2011 issues lacking preventive action plans. 2. Failure to establish and maintain procedures for investigating nonconformities (21 CFR 820.100(a)(2)). The firm failed to elevate serious issues, such as material defects, IQC/OQC nonconformances, and modifications, to the CAPA system. 3. Failure to verify/validate corrective and preventive actions for effectiveness (21 CFR 820.100(a)(4)). Corrective actions were closed without proper verification, and modified equipment was used without documented testing. 4