# China NMPA Inspection - Guangzhou Hanyue Biotechnology Co., Ltd. - July 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/guangzhou-hanyue-biotechnology-co-ltd/a28ad066-29d2-49c0-8155-ba0a07b6e349/
Source feed: China

> China NMPA unannounced inspection for Guangzhou Hanyue Biotechnology Co., Ltd. published July 10, 2018. An unannounced inspection of Guangzhou Hanyue Biotechnology Co., Ltd. was conducted by the National Food and Drug Administration and Guangdong Provinc

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Guangzhou Hanyue Biotechnology Co., Ltd.
- Company Name: Guangzhou Hanyue Biotechnology Co., Ltd.
- Publication Date: 2018-07-10
- Product Type: Cosmetics
- Summary: An unannounced inspection of Guangzhou Hanyue Biotechnology Co., Ltd. was conducted by the National Food and Drug Administration and Guangdong Provincial Food and Drug Administration on June 21-22, 2018. Based on the "Key Points for Cosmetic Production License Inspection," the inspection uncovered 10 serious and 9 general deficiencies, indicating significant non-compliance with cosmetic production license conditions outlined in the "Cosmetic Production Licensing Work Specifications."

Key violations included a severe lack of qualified and healthy personnel, with no health records and expired certificates for management and inspectors. Quality management was critically deficient, lacking essential batch production, inspection, and original record-keeping for products. Facility issues were prominent, as the company produced eye care cosmetics without meeting the required Class 300,000 cleanroom standards, and stored expired or unlabeled products in qualified areas. Equipment management was poor, evidenced by uncalibrated scales, missing purchase/installation documentation, and an absence of water quality monitoring. Material and product control suffered from a lack of supplier management, incomplete labeling, and failure to address expired materials and products. Production management lacked a proper batch system, and sales records after 2017 were unavailable.

As a result, Guangzhou Hanyue Biotechnology Co., Ltd. has been ordered by the Guangdong Provincial Food and Drug Administration to suspend all production and sales of cosmetics immediately. Resumption of operations is contingent upon full rectification of all identified issues and subsequent confirmation by the Guangdong Provincial Food and Drug Administration that all cosmetic production license conditions are met. Rectification progress must also be reported to the State Drug Administration.

Company: https://www.globalkeysolutions.net/companies/guangzhou-hanyue-biotechnology-co-ltd/f9529d17-cc45-4025-8206-27889d6ee789/