# China NMPA Inspection - Shanghai Qisheng Biological Preparations Co., Ltd. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-qisheng-biological-preparations-co-ltd/20ac1f80-357e-4bc3-aec9-3dfa636b8b71/
Source feed: China

> China NMPA unannounced inspection for Shanghai Qisheng Biological Preparations Co., Ltd. published July 16, 2018. Shanghai Qisheng Biological Preparations Co., Ltd. was subject to an unannounced special inspection by the NMPA on June 26-27, 2018, regarding its Inj

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of on-site inspection of Shanghai Qisheng Biological Preparations Co., Ltd.
- Company Name: Shanghai Qisheng Biological Preparations Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: Shanghai Qisheng Biological Preparations Co., Ltd. was subject to an unannounced special inspection by the NMPA on June 26-27, 2018, regarding its Injectable Modified Sodium Hyaluronate Gel. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its appendix for implantable devices, revealed twelve general deficiencies.

Key violations included critical cleanroom control failures, such as humidity exceeding the 45-65% standard (recorded at 77%) and an unmarked, out-of-service pass-through window. Documentation and record-keeping issues were prevalent, including incomplete calibration records, incorrectly dated document changes, and missing preparer information for laboratory reagents. The company also failed to identify and record product technical requirement modifications, neglected to record vacuuming times during filling, and improperly stored hazardous materials in a cleanroom. A significant product quality concern involved a packaging error (incorrect product volume) for which no destruction record was found, despite the company's claim. Additionally, a nitrogen pipeline in the cleanroom was improperly sealed, and storage conditions for a modified sodium hyaluronate intermediate were undefined.

Consequently, the Shanghai Municipal Food and Drug Administration has mandated that Shanghai Qisheng rectify all identified issues within a specified period, assess product safety risks, and recall any potentially hazardous products. Follow-up inspections will be conducted, and the Shanghai FDA is required to report the company's rectification progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/shanghai-qisheng-biological-preparations-co-ltd/57d6cae8-1b3b-4690-a07c-2295dd7c925c/