# China NMPA Inspection - Shanghai Jinxu Biotechnology Co., Ltd. - December 19, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shanghai-jinxu-biotechnology-co-ltd/bf1afdb6-08bf-47cb-b647-c2c678e55b76/
Source feed: China

> China NMPA unannounced inspection for Shanghai Jinxu Biotechnology Co., Ltd. published December 19, 2018. Shanghai Jinxu Biotechnology Co., Ltd. was subject to an unannounced supervision inspection in 2018 by the National and Shanghai Food and Drug Adminis

---

## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shanghai Jinxu Biotechnology Co., Ltd.
- Company Name: Shanghai Jinxu Biotechnology Co., Ltd.
- Publication Date: 2018-12-19
- Product Type: Cosmetics
- Summary: Shanghai Jinxu Biotechnology Co., Ltd. was subject to an unannounced supervision inspection in 2018 by the National and Shanghai Food and Drug Administrations, based on the "Key Points for Cosmetic Production License Inspection." The inspection uncovered one serious and six general deficiencies, indicating significant systemic issues.
The serious defect highlighted a critical breakdown in quality control: the operator and reviewer for weighing records of Gubei Water Town Shower Gel (batch A98YECN) were the same person, compromising independent verification.
General deficiencies spanned several areas. Quality management exhibited incomplete semi-finished product inspection records and a lack of calibration certificates for an autoclave and incubator. Facilities lacked a differential pressure display in a Class 300,000 clean area. Equipment management showed incomplete cleaning status labels on production equipment, missing critical details. In material and product management, raw material pullulan lacked proper location cards and identification details. Production management was also flawed, with incomplete batch production instructions (missing raw material usage) for Gubei Water Town Shower Gel.
Consequently, the Shanghai Municipal Drug Administration is required to order Shanghai Jinxu Biotechnology Co., Ltd. to implement rectifications within a specified period. The company must then report these corrective actions to the Cosmetics Supervision Department of the State Drug Administration within two months, emphasizing the need for robust improvements across all identified areas to ensure regulatory compliance and product quality.

Company: https://www.globalkeysolutions.net/companies/shanghai-jinxu-biotechnology-co-ltd/8ea3b9eb-3205-4b33-a0f7-d726a64cc8c8/