# China NMPA Inspection - Changchun Bio-pharmaceutical Co., Ltd. - September 29, 2016

Source: https://www.keypedia.com/records/china_inspection/changchun-bio-pharmaceutical-co-ltd/aa4782a2-c203-40f8-9665-d945a460e1db
Source feed: China

> China NMPA unannounced inspection for Changchun Bio-pharmaceutical Co., Ltd. published September 29, 2016. An unannounced inspection of Changchun Boao Biochemical Pharmaceutical Co., Ltd. was conducted from July 25-28, 2016, by the State Food and Drug Admin

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## Details

- Record Type: CHINA_INSPECTION
- Title: Report on Follow-up Inspection of Changchun Bio-pharmaceutical Co., Ltd.
- Company Name: Changchun Bio-pharmaceutical Co., Ltd.
- Publication Date: 2016-09-29
- Product Type: Drugs
- Summary: An unannounced inspection of Changchun Boao Biochemical Pharmaceutical Co., Ltd. was conducted from July 25-28, 2016, by the State Food and Drug Administration and Jilin Provincial Food and Drug Administration. The inspection uncovered several critical violations of regulatory standards. Key issues included the production of inosine peptide injection deviating from its approved process, specifically regarding the type of rabbit raw material used and an unvalidated change in the ultrafiltration method for virus inactivation. The company also failed to perform adequate quality control testing on raw materials and purified water, evidenced by inaccurate records, an improperly functioning incubator, missing raw material inspection reports, and an inspector's flawed infrared identification process. Additionally, the facility demonstrated insufficient controls to prevent cross-contamination during the final processing of animal tissues and exhibited unreasonable personnel permissions and incorrect system time settings for a sterilization cabinet, compromising data integrity. These actions violated the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. As a result, the Jilin Provincial Food and Drug Administration revoked the company's "Drug GMP Certificate" for small-volume injections. The State Food and Drug Administration further directed Jilin Provincial FDA to investigate these irregularities and supervise the implementation of risk control measures for all related products.

Company: https://www.keypedia.com/companies/changchun-bio-pharmaceutical-co-ltd/264ddfc6-9c6a-410c-a611-c2c5d608d8a3