# China NMPA Inspection - Sichuan Altai Medical Equipment Co., Ltd. - July 24, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/sichuan-altai-medical-equipment-co-ltd/aa8579a8-5cec-48df-93bc-7d4f8553dc74/
Source feed: China

> China NMPA unannounced inspection for Sichuan Altai Medical Equipment Co., Ltd. published July 24, 2017. An unannounced inspection of Sichuan Altai Medical Device Co., Ltd., conducted from July 5-6, 2017, identified 17 significant deficiencies related to 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Sichuan Altai Medical Equipment Co., Ltd.
- Company Name: Sichuan Altai Medical Equipment Co., Ltd.
- Publication Date: 2017-07-24
- Product Type: Device
- Summary: An unannounced inspection of Sichuan Altai Medical Device Co., Ltd., conducted from July 5-6, 2017, identified 17 significant deficiencies related to its Spinal Internal Fixation System. The inspection, based on *Good Manufacturing Practice for Medical Devices* and its appendix for implantable devices, revealed multiple issues impacting product quality and safety.

Key violations included inadequate facility controls, such as a lack of rodent control and insufficient warehouse space. The company failed to properly assess calibration results for measuring instruments and ensure consistency in optical measuring instrument assessments. Significant documentation control issues were noted, with scattered and inconsistent product technical documents, uncontrolled process flow charts, and special processes not explicitly defined.

Furthermore, the company did not follow its own procedures for design and development changes, including review and approval for outsourcing sample production. Procurement controls were deficient, lacking proper categorization of purchased items and thorough evaluation of supplier inspection reports for raw materials. Production control deficiencies included inconsistent cleaning validation, poor product traceability, inadequate protection for raw materials, and a lack of internal control standards for finished product surface defects. The quality management system showed weaknesses in its finished product release procedures and unverified computer software for manufacturing equipment.

The Sichuan Provincial Food and Drug Administration was mandated to order the company to rectify these issues promptly, conduct follow-up inspections, assess product safety risks, and initiate recalls if necessary. A report on the rectification status must be submitted to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/sichuan-altai-medical-equipment-co-ltd/ee3c05fa-fc61-4770-94a8-073dcb455bdc/