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

Source: https://www.globalkeysolutions.net/records/china_inspection/hunan-hongkai-biotechnology-co-ltd/42dc8c61-308a-4195-899f-ceeb77b1c9e6/
Source feed: China

> China NMPA unannounced inspection for Hunan Hongkai Biotechnology Co., Ltd. published August 10, 2017. On August 4, 2017, the State Food and Drug Administration announced findings from a recent unannounced inspection of Hunan Hengtian Biotechnology Co.,

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## Details

- Record Type: CHINA_INSPECTION
- Title: Announcement No. 130 of 2017 from the State Administration for Market Regulation regarding the suspension of production and rectification of Hunan Hengtian Biotechnology Co., Ltd.
- Company Name: Hunan Hongkai Biotechnology Co., Ltd.
- Publication Date: 2017-08-10
- Product Type: Device
- Summary: On August 4, 2017, the State Food and Drug Administration announced findings from a recent unannounced inspection of Hunan Hengtian Biotechnology Co., Ltd. The inspection revealed significant deficiencies across the company's quality management system, non-compliant with the Good Manufacturing Practice for Medical Devices and related regulations. Key issues identified included inadequate plant facilities, such as chemical storage within a biological processing area with corroded labels and missing usage records, and an inspection area for frozen raw materials lacking proper freezing capabilities. Equipment non-conformities were found, including the company possessing manufacturing equipment for only 3 of 22 registered product specifications and a cleanroom air conditioning unit with a non-functional pressure gauge and incomplete operating procedures. Procurement records were deficient, with missing official seals on quarantine reports and inability to link animal quarantine certificates to specific product batches. Production management exhibited critical failures: the "biochemical treatment" process was not designated as a special process, operator-stated treatment times contradicted validation reports, and key parameters for a sealing machine lacked validation. Furthermore, production records showed discrepancies in treatment dates and missing critical parameter timings. Quality control management was also flawed, with inconsistent titrant dilution records, lack of temperature correction during testing, absent pH meter calibration records, and a product release system that failed to require complete batch production records or verification of all process flows. As a result, Hunan Hengtian Biotechnology Co., Ltd. has been ordered to immediately cease production for rectification by the Hunan Provincial Food and Drug Administration. The company must assess product safety risks and recall any hazardous products according to recall administration measures. Production can only resume after all rectification measures are completed and a follow-up inspection is passed. Violations of the Regulations on the Supervision and Administration of Medical Devices will face serious legal action.

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