# China NMPA Inspection - Tianjin Soma Technology Co., Ltd. - June 21, 2023

Source: https://www.globalkeysolutions.net/records/china_inspection/tianjin-soma-technology-co-ltd/a1aad1a6-b50d-4e83-a8a3-0aa03b334e3b/
Source feed: China

> China NMPA unannounced inspection for Tianjin Soma Technology Co., Ltd. published June 21, 2023. On June 21, 2023, the National Medical Products Administration (NMPA) announced unannounced inspections revealing significant quality management syste

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 28 of 2023 from the National Medical Products Administration regarding the results of unannounced inspections of three companies, including Tianjin Soma Technology Co., Ltd.
- Company Name: Tianjin Soma Technology Co., Ltd.
- Publication Date: 2023-06-21
- Product Type: devices
- Summary: On June 21, 2023, the National Medical Products Administration (NMPA) announced unannounced inspections revealing significant quality management system deficiencies at three medical device companies. Tianjin Soma Technology Co., Ltd. was found in violation of the Good Manufacturing Practice for Medical Devices and its Sterile Medical Devices Appendix. Issues included insufficient inspection personnel training, inadequate records for testing materials and retained samples, and the absence of quality agreements with major suppliers. Production management suffered from inconsistent documentation, incomplete process validation, and traceability failures, along with unlabeled semi-finished products. Quality control procedures were also deficient, with incomplete instructions and inconsistent sterility testing methods. The Tianjin Municipal Drug Administration has suspended production, mandating a safety risk assessment, potential product recalls, and comprehensive rectification before re-inspection for resumption. Shenzhen Anter Medical Co., Ltd. was non-compliant with the Good Manufacturing Practice for Medical Devices and its Implantable Medical Devices Appendix. Deficiencies included poorly managed factory facilities with inadequate environmental controls, improper storage, and a lack of quality assurance agreements for outsourced processes. Production management showed insufficient process verification and traceability problems, including mismatched operators. Quality control issues involved incorrect sterilization testing dates and a failure to specify release standards for sterilized products. The Guangdong Provincial Drug Administration ordered a production suspension, a safety risk assessment, potential recalls, and mandatory rectification and re-inspection for resuming operations. Beijing Datang Dingshi Eye Care Products Co., Ltd., though already shut down, was cited because its management representative failed to maintain an effective quality management system, not meeting Good Manufacturing Practice for Medical Devices requirements. The Beijing Municipal Drug Administration will monitor the company, requiring a complete quality system overhaul and re-inspection if production resumes.

Company: https://www.globalkeysolutions.net/companies/tianjin-soma-technology-co-ltd/6135f956-65a5-4746-bb17-9799ff75ccfe/