# China NMPA Inspection - Hunan Hongkai Biotechnology Co., Ltd. - October 30, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-hongkai-biotechnology-co-ltd/cfcd332b-1f99-4888-9b43-42100d7b11a3/
Source feed: China

> China NMPA unannounced inspection for Hunan Hongkai Biotechnology Co., Ltd. published October 30, 2018. An unannounced inspection of Hunan Hengtian Biotechnology Co., Ltd. was conducted by the FDA NMPA from October 16th to October 17th, 2018. The inspect

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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: 2018-10-30
- Product Type: Device
- Summary: An unannounced inspection of Hunan Hengtian Biotechnology Co., Ltd. was conducted by the FDA NMPA from October 16th to October 17th, 2018. The inspection, focusing on compliance for their Intervertebral Fusion Device, was based on Good Manufacturing Practice (GMP) standards, particularly those for implantable medical devices.

Several critical issues were identified, highlighting deficiencies in quality management systems. Key violations included the absence of a designated return/recall area in the finished product warehouse and inadequate maintenance procedures and records for purified water systems. The company's record retention policy for quality records, set at three years, was deemed insufficient for long-term implantable products. Procurement controls were found to be incomplete, lacking specifications for supplier evaluation and documentation for certain materials like medical alcohol.

Furthermore, batch production records exhibited significant errors, such as missing process parameters, unstandardized corrections, and absent preparation records for treatment solutions. Measuring instrument verification records contained discrepancies, and inspection records were incomplete, lacking essential details like instrument and material batch numbers. Deficiencies in employee training documentation and non-standardized labeling of water systems and pipelines within cleanrooms also surfaced.

Hunan Hengtian Biotechnology Co., Ltd. has been mandated to rectify all identified issues within a specified timeframe, assess product safety risks, and recall any potentially hazardous products. The Hunan Provincial Food and Drug Administration is responsible for follow-up inspections and reporting the company's rectification progress to the National Medical Products Administration.

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