# China NMPA Inspection - Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd. - December 05, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/kaifeng-shengding-pharmaceutical-technology-development-co-ltd/66cd86ce-a505-4c90-b4f2-342d96c4d6f9/
Source feed: China

> China NMPA unannounced inspection for Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd. published December 05, 2017. Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd. underwent an unannounced inspection by the NMPA on October 27-28, 2017, revealing se

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## Details

- Record Type: CHINA_INSPECTION
- Title: Forwarding the notification from the Henan Provincial Food and Drug Administration regarding the surprise inspection of Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd.
- Company Name: Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd.
- Publication Date: 2017-12-05
- Product Type: Cosmetics
- Summary: Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd. underwent an unannounced inspection by the NMPA on October 27-28, 2017, revealing several critical non-compliance issues in its operations. Deficiencies in the production environment included the absence of equipment status labels, product names, and batch numbers in some workshops, alongside a non-functional air conditioning system in the cleanroom. Significant concerns were identified in raw material management. Twenty barrels of alcohol lacked crucial identification labels such as name, batch number, manufacturer, and production date, and were unsafely stored with other raw materials without being treated as flammable substances. The facility also lacked a dedicated cool, dark storage area, despite explicit storage requirements on some raw material packaging. Furthermore, discrepancies were found between raw material contents and their location cards. Quality control and storage practices were also found wanting. The sample retention room did not comprehensively cover all product batches or varieties. The packaging material warehouse was deficient in lighting, lacked location cards, and stored some inner packaging exposed. In the finished product warehouse, despite categorical organization, there were no traceable records for inventory batches, warehousing, or sales. The inspection also highlighted a general ineffectiveness in the implementation of various management systems. As a result of these findings, Kaifeng Shengding Pharmaceutical Technology Development Co., Ltd. has been ordered to promptly rectify all identified issues. The case has been escalated to the Kaifeng Municipal Bureau for investigation and appropriate legal action in accordance with relevant regulations.

Company: https://www.globalkeysolutions.net/companies/kaifeng-shengding-pharmaceutical-technology-development-co-ltd/8e2713b6-c261-4588-af33-c23071234161/