# China NMPA Inspection - Shanghai ZJ Bio-Tech Co., Ltd. - April 11, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-zj-bio-tech-co-ltd/da4b593a-09ac-4e10-9b7e-278424db09a0/
Source feed: China

> China NMPA unannounced inspection for Shanghai ZJ Bio-Tech Co., Ltd. published April 11, 2017. A surprise inspection report, published on April 11, 2017, by the Shanghai Municipal Food and Drug Administration, detailed critical findings concerni

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Shanghai ZJ Biotech Co., Ltd.
- Company Name: Shanghai ZJ Bio-Tech Co., Ltd.
- Publication Date: 2017-04-11
- Product Type: devices
- Summary: A surprise inspection report, published on April 11, 2017, by the Shanghai Municipal Food and Drug Administration, detailed critical findings concerning Shanghai ZJ Bio-Tech Co., Ltd. The inspection revealed that the company's operations did not adhere to the stringent requirements outlined in the Good Manufacturing Practice for Medical Devices. Specifically, the regulatory body identified significant deficiencies within the company's overall quality management system. This non-compliance indicates potential risks regarding the quality, safety, and efficacy of medical devices manufactured or handled by the company. As a direct consequence of these findings, Shanghai ZJ Bio-Tech Co., Ltd. has been formally ordered to implement immediate corrective actions. The directive mandates the company to rectify all identified deficiencies within its quality management system and operational practices within a specified timeframe. This regulatory action, under the oversight of the National Medical Products Administration (NMPA), underscores the commitment of Chinese authorities to uphold high standards in medical device manufacturing and ensure public health and safety.

Company: https://www.globalkeysolutions.net/companies/shanghai-zj-bio-tech-co-ltd/3d0dbf4f-97d1-4e4d-98b7-70b19606c3ee/