AMO (Hangzhou) Co., Ltd. – FDA EIR, Aug 13, 2015

An FDA inspection of Abbott AMO (Hangzhou) Co., Ltd. was conducted from August 10 to August 13, 2015, in Hangzhou, China. This routine Medical Device Level II inspection, performed under the "Inspection of Medical Device Manufacturers" regulatory framework, utilized the Quality System Inspection Technique (QSIT). The inspection evaluated various aspects including management controls, design controls, corrective and preventive actions (CAPA), production and process controls, sterilization process controls, and complaint handling for their sterile contact lens care products, which are classified as Class II and Class III medical devices and OTC drugs. A review of prior inspection history noted a single observation from a 2012 inspection regarding inadequate device history record maintenance; however, this issue was verified as corrected during the current assessment. Significantly, at the conclusion of the 2015 inspection, no Form FDA-483, "Inspectional Observations," was issued, and no verbal observations were discussed with company management. Consequently, no specific violations or required actions were identified for Abbott AMO (Hangzhou) Co., Ltd. stemming from this inspection, indicating compliance with the assessed regulatory requirements.