On April 26, the CFDA issued a notice saying that the General Administration conducted a flight inspection of Jiangsu Hailun Contact Lens Co., Ltd. (hereinafter referred to as Helen Contact Lens). During the examination, Helen contact lenses were found to have the following problems:
The sterilization confirmation record of the product is not provided. In the sterilization confirmation record of the common product, the equipment number in the performance confirmation record of the No. 4 sterilizer does not match the field equipment number, and does not comply with the " Medical Device Production Quality Management Regulations" and In the relevant appendix (hereinafter referred to as the "Specification"), the enterprise shall confirm the special process of production and keep records, including requirements for confirmation plan, confirmation method, operator, result evaluation, and reconfirmation.
According to the “Supplier's Performance Evaluation and Control Tableâ€, the actual consumption of the PP box, PP cup, glass bottle primary packaging materials in 2016 and the 2015 inventory records is higher than the initial packaging material consumption submitted by the company. Some products have no production records, and some batches of products are spot-checked. The number of products in the labeling and packaging process is inconsistent with the number of lenses in the injection molding process, and the PP particle batch number is not filled in the injection molding process, and each batch of products that do not meet the "Specifications" should have a production record. And meet the requirements of traceability.
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