# China NMPA Inspection - Hunan Hongkai Biotechnology Co., Ltd. - August 10, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-hongkai-biotechnology-co-ltd/f8b31631-7832-4dc0-a299-50f574f56343
Source feed: China

> China NMPA unannounced inspection for Hunan Hongkai Biotechnology Co., Ltd. published August 10, 2017. During an unannounced inspection on July 18-19, 2017, Hunan Hengtian Biotechnology Co., Ltd., a manufacturer of Xenogeneic Cortical Bone Internal Fixa

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hunan Hengtian Biotechnology Co., Ltd.
- Company Name: Hunan Hongkai Biotechnology Co., Ltd.
- Publication Date: 2017-08-10
- Product Type: Device
- Summary: During an unannounced inspection on July 18-19, 2017, Hunan Hengtian Biotechnology Co., Ltd., a manufacturer of Xenogeneic Cortical Bone Internal Fixation Devices, was found to have significant deficiencies. The inspection, based on Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, identified four serious defects and fifteen general deficiencies.Serious issues included discrepancies between registered product specifications and actual production capabilities, critical inconsistencies in the biochemical treatment process validation and record-keeping, inadequate validation of continuous sealing machine parameters, and insufficient product release criteria. The company could not provide process equipment for most of its registered product specifications and showed conflicting records for biochemical treatment dates and durations.General deficiencies encompassed poor chemical storage and raw material handling, lack of comprehensive operating procedures for equipment maintenance, and widespread problems with document control, including unreplaced revised documents, incomplete record-keeping, and unresolved internal audit findings. Further issues involved design control gaps, inadequate raw material traceability, discrepancies in packaging material descriptions, and lapses in laboratory testing procedures, such as titrant concentration and equipment calibration. Additionally, several cleanroom deficiencies were noted, including unsuitable sanitary facilities, inappropriate equipment storage, and insufficient environmental monitoring records.As a result of these systemic production quality management problems, the Hunan Provincial Food and Drug Administration has ordered Hunan Hengtian Biotechnology Co., Ltd. to immediately suspend production for rectification.

Company: https://www.globalkeysolutions.net/companies/hunan-hongkai-biotechnology-co-ltd/e469bec1-5656-4756-91ca-72615f33761d