From March 22 to 27, 2020 and April 27 to 29, 2020, the Company accepted and passed the on-site inspection by the Food and Drug Inspection Center of the on-site inspections by the Center for Food and Drug Inspection of NMPA regarding the registration of Group A and Group C Meningococcal Conjugate Vaccine.
From April 26 to 29, 2020, the Company accepted the on-site inspection on GMP compliance of Group A and Group C Meningococcal Conjugate Vaccine and the follow-up inspection on Haemophilus Influenzae Type b Conjugate Vaccine by Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring, and passed the inspections.
The inspection is detailed in the following table. Besides, no penalties were made against the Company's products due to quality since their launch.
Inspection Statistics
S/N | Time | Institute | Details | Results |
1 | March 22 to 27, 2020 (Phase I) April 27 to 29, 2020 (Phase II) | Center for Food and Drug Inspection of NMPA | On-site inspection regarding the registration of Group A and Group C Meningococcal Conjugate Vaccine | Passed |
2 | April 26 to 29, 2020 | Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring | On-site inspection on GMP compliance of Group A and Group C Meningococcal Conjugate Vaccine Follow-up inspection on Haemophilus Influenzae Type b Conjugate Vaccine | Passed |