# China NMPA Inspection - Yunnan Haodi Medical Instrument Co., Ltd. - July 14, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/yunnan-haodi-medical-instrument-co-ltd/2db61900-df50-4782-a838-b0b676d519a1/
Source feed: China

> China NMPA unannounced inspection for Yunnan Haodi Medical Instrument Co., Ltd. published July 14, 2017. A recent unannounced inspection by the State Food and Drug Administration revealed significant deficiencies in the quality management system of Yunnan

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 107 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Yunnan Haodi Medical Devices Co., Ltd.
- Company Name: Yunnan Haodi Medical Instrument Co., Ltd.
- Publication Date: 2017-07-14
- Product Type: Device
- Summary: A recent unannounced inspection by the State Food and Drug Administration revealed significant deficiencies in the quality management system of Yunnan Haodi Medical Device Co., Ltd. Conducted under the "Good Manufacturing Practice for Medical Devices" framework, the inspection identified multiple areas requiring urgent corrective action.

Key violations included severe understaffing in the quality department, incompatible with the company's production capacity. Facility issues were prominent, with faulty pressure gauges, insufficient cleanroom pressure differentials, improper washing of sterile work clothes, and inadequate temperature/humidity control. The company also failed to evaluate the impact of gases directly contacting products and improperly designed clean area drainage.

Documentation management was lacking, with controlled documents not properly stamped and inaccurate recording of critical test data, compromising traceability. Deficiencies in design and development procedures included missing descriptions for design conversion and risk management, along with a failure to appropriately manage, review, and validate significant product and process changes, such as alterations to cleaning processes or assembly methods.

Procurement procedures were not followed, lacking essential plans and lists, and raw material inspection standards omitted biological performance criteria. Additionally, the company did not procure biologically evaluated materials as required. Production management suffered from quantity discrepancies in batch records and inadequate process monitoring, failing to clearly define the relationship between production and sterilization batch numbers. Finally, quality control records lacked original particle analyzer data, and the nonconforming product procedure failed to specify serious nonconformities.

Yunnan Haodi Medical Device Co., Ltd. is required to implement comprehensive corrective actions across all these areas to ensure full compliance with the stipulated regulatory standards.

Company: https://www.globalkeysolutions.net/companies/yunnan-haodi-medical-instrument-co-ltd/827fb474-5b21-49de-9ea0-cfa6803a6f33/