# China NMPA Inspection - Beijing Youcai Jinghang Biotechnology Co., Ltd. - July 25, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/beijing-youcai-jinghang-biotechnology-co-ltd/f1b7fc17-e6e7-4eed-b575-43402d227ef7/
Source feed: China

> China NMPA unannounced inspection for Beijing Youcai Jinghang Biotechnology Co., Ltd. published July 25, 2017. An unannounced compliance inspection of Beijing Youcai Jinghang Biotechnology Co., Ltd., conducted from July 4 to July 6, 2017, identified significant

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Flight Inspection of Beijing Youcai Jinghang Biotechnology Co., Ltd.
- Company Name: Beijing Youcai Jinghang Biotechnology Co., Ltd.
- Publication Date: 2017-07-25
- Product Type: Device
- Summary: An unannounced compliance inspection of Beijing Youcai Jinghang Biotechnology Co., Ltd., conducted from July 4 to July 6, 2017, identified significant non-compliance issues related to the manufacturing of Titanium Alloy Artificial Shoulder Joints. The inspection, based on the Good Manufacturing Practice for Medical Devices and its appendix for implantable devices, revealed eight general defects.

Key violations included deficiencies in raw material storage, where materials were improperly placed and lacked environmental controls. The company's recall procedures were incomplete, omitting public notification requirements as mandated by regulatory guidelines. Issues also extended to quality control, with incomplete records for non-conforming and scrapped products, and discrepancies between documented cleaning processes and actual operational frequencies. Furthermore, equipment calibration was overlooked, and the effectiveness of disinfection processes remained unverified. Workplace safety was also compromised, as evidenced by inadequate operator attire and insufficient control over hazardous chemicals, including improper storage and unlabeled waste.

The regulatory authority has mandated that Beijing Youcai Jinghang Biotechnology Co., Ltd. rectify all identified issues within a specified timeframe. The company is required to analyze root causes, assess product safety risks, and implement necessary risk control measures. For any products posing safety hazards, a recall must be initiated. The Beijing Municipal Food and Drug Administration will conduct follow-up inspections and report the rectification progress to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/beijing-youcai-jinghang-biotechnology-co-ltd/1b9f235e-c381-49e3-8ad2-4a76b1f4f1da/