# China NMPA Inspection - Henan Xinpiaoan High-Tech Co., Ltd. - November 03, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-xinpiaoan-high-tech-co-ltd/4ac3296a-240e-41f0-8285-b55add206328/
Source feed: China

> China NMPA unannounced inspection for Henan Xinpiaoan High-Tech Co., Ltd. published November 03, 2017. An unannounced inspection by the State Food and Drug Administration (SFDA), with findings announced on November 1, 2017, uncovered critical deficienci

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 174 of 2017 from the State Administration of Taxation regarding the suspension of production and rectification of Henan Xinpiaoan High-Tech Co., Ltd.
- Company Name: Henan Xinpiaoan High-Tech Co., Ltd.
- Publication Date: 2017-11-03
- Product Type: Device
- Summary: An unannounced inspection by the State Food and Drug Administration (SFDA), with findings announced on November 1, 2017, uncovered critical deficiencies in the quality management system of Henan Xinpiaoan High-Tech Co., Ltd., a manufacturer of medical petroleum jelly dressing. The company was found in serious non-compliance with the "Good Manufacturing Practice for Medical Devices" and other relevant regulations.

Key issues identified included inadequate plant and facility controls, such as faulty HVAC systems and obstructed ventilation. Production equipment was unsuitable for the manufacturing scale, with small-capacity tools used for large batches, and the air purification system lacked proper validation and restart verification. Document management was substandard, highlighted by an unapproved and unsigned quality manual. Procurement practices were deficient, lacking qualified supplier lists and formal quality agreements for critical raw materials like gauze pads. Production management showed deviations from documented procedures and lacked raw material traceability in batch records. Furthermore, quality control was insufficient, with missing or uncontrolled incoming inspection records for essential raw materials.

Consequently, the SFDA has ordered Henan Xinpiaoan High-Tech Co., Ltd. to immediately cease production for comprehensive rectification. The company must assess product safety risks, recall any potentially hazardous products, and implement all necessary corrective actions. Production can only resume after successful completion of rectification and a follow-up inspection by the provincial food and drug administration. Failure to comply with medical device regulations will lead to severe legal penalties.

Company: https://www.globalkeysolutions.net/companies/henan-xinpiaoan-high-tech-co-ltd/6d8359b1-81b0-43ce-8e4f-8a4927ea06aa/