# China NMPA Inspection - Qingdao Newbayo Optical Manufacturing Co., Ltd. - August 17, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qingdao-newbayo-optical-manufacturing-co-ltd/5bb8940e-c2be-45b7-a603-60be534d6f64/
Source feed: China

> China NMPA unannounced inspection for Qingdao Newbayo Optical Manufacturing Co., Ltd. published August 17, 2018. An unannounced inspection of Qingdao Newbayo Optical Manufacturing Co., Ltd. was conducted on July 24-25, 2018, based on the regulatory framework of G

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Qingdao Newbay Optical Manufacturing Co., Ltd.
- Company Name: Qingdao Newbayo Optical Manufacturing Co., Ltd.
- Publication Date: 2018-08-17
- Product Type: Device
- Summary: An unannounced inspection of Qingdao Newbayo Optical Manufacturing Co., Ltd. was conducted on July 24-25, 2018, based on the regulatory framework of Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection identified serious and general deficiencies in the company's manufacturing processes for soft hydrophilic contact lenses. Serious violations included inadequate temperature control and monitoring for critical heating plates, missing production records for several batches, and non-adherence to product technical requirements for lens diameter and power measurements, specifically using incorrect solutions and temperatures. Furthermore, finished product inspection reports lacked required sterility and osmotic pressure tests, and original sterility records were absent. Significant discrepancies were found in non-conforming product records, and the sterilization process validation failed to include microbial load challenge testing. General deficiencies encompassed inventory discrepancies, inconsistent warehouse environmental controls, poor equipment maintenance, and a lack of calibration records for testing equipment. Issues with compressed air purification monitoring, reagent labeling, and non-compliance with internal sample retention protocols were also noted. As a result, the company was ordered to immediately suspend production for rectification. They are required to assess product safety risks, recall any hazardous products, and can only resume operations after all deficiencies are corrected and a follow-up inspection is passed. The provincial administration will report these actions to the National Medical Products Administration and publicly disclose them.

Company: https://www.globalkeysolutions.net/companies/qingdao-newbayo-optical-manufacturing-co-ltd/ebd70c65-07a4-4231-a0c4-ade98f4a30cc/