# China NMPA Inspection - Henan Chunzhen Biotechnology Co., Ltd. - December 05, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/henan-chunzhen-biotechnology-co-ltd/b9125503-8092-410c-9705-18e48f1f3f02/
Source feed: China

> China NMPA unannounced inspection for Henan Chunzhen Biotechnology Co., Ltd. published December 05, 2017. An unannounced inspection of Henan Chunzhen Biotechnology Co., Ltd. on November 4, 2017, revealed several critical deficiencies in its manufacturing p

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## Details

- Record Type: CHINA_INSPECTION
- Title: Forwarding the notification from the Henan Provincial Food and Drug Administration regarding the unannounced inspection of Henan Chunzhen Biotechnology Co., Ltd.
- Company Name: Henan Chunzhen Biotechnology Co., Ltd.
- Publication Date: 2017-12-05
- Product Type: Cosmetics
- Summary: An unannounced inspection of Henan Chunzhen Biotechnology Co., Ltd. on November 4, 2017, revealed several critical deficiencies in its manufacturing practices and regulatory compliance. Investigators found that a finished product warehouse area had been improperly converted into a workshop, containing unauthorized production equipment and materials, a discrepancy with the company's license documents issued under the relevant regulatory framework. The company was also producing and shipping multiple batches of unregistered cosmetic products, including Pure Zhenyuan Aloe Vera Gel, between 2016 and 2017, without maintaining proper finished product inventory records. Significant issues were identified in facility hygiene and environmental control. There was a notable absence of established hygiene and cleaning/disinfection management systems for clean areas. Return air filters in the filling room were heavily soiled, and crucial differential pressure display devices were either missing or damaged across various clean workshop areas. Furthermore, production equipment and laboratory instruments lacked proper status indicators, and warehouses for raw materials and finished products lacked essential temperature and humidity control. Raw material management was also deficient, with missing location cards, incomplete batch information on packaging, and a lack of required purchase invoices and factory inspection reports for certain materials. Consequently, Henan Chunzhen Biotechnology Co., Ltd. was ordered to rectify these issues, and the case was escalated to the Luohe Municipal Bureau for further investigation and legal action.

Company: https://www.globalkeysolutions.net/companies/henan-chunzhen-biotechnology-co-ltd/02abe0c4-7be5-4763-a0dd-aab35aaf3602/