# China NMPA Inspection - Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shengshi-fujian-ophthalmic-technology-development-co-ltd/4af5ef10-31eb-43d3-bfe9-aa3968aebdca/
Source feed: China

> China NMPA unannounced inspection for Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd. published January 10, 2018. Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd. was subject to an unannounced compliance inspection from November 20-21, 2017, conducted

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd.
- Company Name: Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd. was subject to an unannounced compliance inspection from November 20-21, 2017, conducted by the FDA NMPA. The inspection, guided by the *Good Manufacturing Practice for Medical Devices* framework, uncovered eight deficiencies, including four critical and four general issues.

Key violations involved significant gaps in the company's quality management system. Specifically, there was an absence of documentation for the quality manager's appointment, responsibilities, and performance records, alongside a failure to provide evidence of other quality management personnel fulfilling their duties. The company's overarching "Quality Management System" was deemed impractical, not aligned with current regulations or the enterprise's actual operations, and did not encompass the entire medical device operation process. Other issues included insufficient pre-job training records, improper zoning within the warehouse's shipping area, and a lack of calibration or verification records for environmental monitoring equipment. Furthermore, a configured computer information management system was not actively utilized, and no dedicated personnel were assigned to monitor and report medical device adverse events.

Consequently, the Fujian Provincial Food and Drug Administration was directed to order Shengshi (Fujian) Ophthalmic Technology Development Co., Ltd. to rectify all identified issues within a specified period. Follow-up inspections are mandated, and the administration must report the company's rectification progress to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/shengshi-fujian-ophthalmic-technology-development-co-ltd/4695ef53-726c-499c-b956-dad4e2f04ce3/