# China NMPA Inspection - Zhuhai Yibang Pharmaceutical Co., Ltd. - January 18, 2019

Source: https://www.globalkeysolutions.net/records/china_inspection/zhuhai-yibang-pharmaceutical-co-ltd/06cec0eb-8cb7-494a-8804-408244af43a9/
Source feed: China

> China NMPA unannounced inspection for Zhuhai Yibang Pharmaceutical Co., Ltd. published January 18, 2019. An unannounced inspection of Zhuhai Yibang Pharmaceutical Co., Ltd. was conducted by the National Food and Drug Administration Inspection Center and Z

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of the Results of the Surprise Inspection and Handling of Zhuhai Yibang Pharmaceutical Co., Ltd.
- Company Name: Zhuhai Yibang Pharmaceutical Co., Ltd.
- Publication Date: 2019-01-18
- Product Type: Drugs
- Summary: An unannounced inspection of Zhuhai Yibang Pharmaceutical Co., Ltd. was conducted by the National Food and Drug Administration Inspection Center and Zhuhai Municipal Food and Drug Administration from June 21-24, 2018. The inspection revealed significant violations of the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). Key issues included repeated failures in sterility testing for products like Clindamycin Phosphate for Injection and Voriconazole for Injection. The company released these products after a second satisfactory test without proper deviation analysis or investigation, even when initial tests failed. Furthermore, during a power outage, the company neglected to conduct a comprehensive risk assessment for sterility tests affected by uncontrolled culture temperatures or resample affected batches. Production process controls also showed serious deficiencies. Environmental monitoring for dust particles and bacteria in sterile areas repeatedly exceeded acceptable limits, yet the company failed to conduct thorough investigations, risk assessments, or implement effective corrective actions. Record inconsistencies were noted, and a concerning practice involved the re-use of rubber stoppers through multiple sterilization cycles without adequate risk assessment. As a result of these findings, Zhuhai Yibang Pharmaceutical Co., Ltd. was required to suspend production for rectification. The Guangdong Provincial Drug Administration oversaw the recall of affected products, and the company's Good Manufacturing Practice certificates were subsequently revoked. These actions underscore severe deviations from essential quality and safety standards in pharmaceutical manufacturing.

Company: https://www.globalkeysolutions.net/companies/zhuhai-yibang-pharmaceutical-co-ltd/f2425f82-4532-463d-9e4f-4667cba8a034/