Simplified Chinese
The company has successfully passed the adverse drug reaction inspection.
Release date:
2018-10-23
Author:
Quality Assurance Department, Wang Li
Source:
Abstract
From October 11 to October 12, 2018, an inspection team comprising inspectors from the Beijing Drug Adverse Reaction Monitoring Center and experts from the Daxing District Food and Drug Administration of Beijing conducted a drug adverse reaction inspection of our company’s Haemophilus influenzae type b conjugate vaccine, acellular pertussis–diphtheria–tetanus–Haemophilus influenzae type b combination vaccine, and measles–rubella live attenuated combined vaccine.
During the inspection, the review team conducted interviews with personnel from the production workshop, the Quality Control (QC) department, the Registration Department, the General Management Office, and the Government and Medical Affairs Department, and reviewed relevant documentation on adverse drug reactions. Inspectors raised numerous questions on-site, which were thoroughly addressed by staff from each department. Ultimately, the inspection team expressed their approval, and the facility successfully passed this adverse drug reaction audit.
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