# China NMPA Inspection - Hangzhou Puji Pharmaceutical Technology Development Co., Ltd. - August 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/hangzhou-puji-pharmaceutical-technology-development-co-ltd/b69e7dad-a8d3-409b-849e-41f71bdfc758/
Source feed: China

> China NMPA unannounced inspection for Hangzhou Puji Pharmaceutical Technology Development Co., Ltd. published August 07, 2017. An unannounced inspection of Hangzhou Puji Pharmaceutical Technology Development Co., Ltd., conducted from February 13-16, 2017, revealed significant 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hangzhou Puji Pharmaceutical Technology Development Co., Ltd.
- Company Name: Hangzhou Puji Pharmaceutical Technology Development Co., Ltd.
- Publication Date: 2017-08-07
- Product Type: Drugs
- Summary: An unannounced inspection of Hangzhou Puji Pharmaceutical Technology Development Co., Ltd., conducted from February 13-16, 2017, revealed significant quality control and regulatory non-compliance. Inspectors found widespread falsification of product production quality process control data, including intermediate and finished product testing results, microbial limits, and temperature records. The company also concealed data related to substandard products and manipulated its QC laboratory computer system time. Furthermore, the inspection identified the use of raw materials, intermediates, and semi-finished products that failed to meet quality standards, such as microbially substandard plasma and intermediates with unacceptable purity, endotoxin, and microbial limits. A critical inconsistency was noted between the actual production process, specifically in the catalyst activation step, and the process documented in the product registration. The company also failed to conduct essential research and validation for significant production process and batch changes, including alterations to ultrafiltration membranes, filtration materials, and batch sizes, demonstrating a severe lack of change control. These violations contravened the Drug Administration Law of the People's Republic of China, its Implementation Regulations, and the Good Manufacturing Practice for Pharmaceuticals. As a result, authorities ordered the sealing of the company's porcine fibrin adhesive inventory, revocation of its GMP certificates, recall of all sold products, and a full investigation and legal punishment for its illegal activities.

Company: https://www.globalkeysolutions.net/companies/hangzhou-puji-pharmaceutical-technology-development-co-ltd/6c4c5712-93c3-47f3-a06f-b2a5913f0575/