Share:

Inspection & Penalty

2021-05-29

From May 27 to 29 2021, the Company accepted and passed the Vaccination inspections on Group A and Group C Meningococcal Conjugate Vaccine,Haemophilus Influenzae Type b Conjugate Vaccine by the National Center for vaccine inspection.


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

May 27 to 29, 2021

National Center for vaccine inspection

Group A and Group C Meningococcal Conjugate Vaccine,Haemophilus Influenzae Type b Conjugate Vaccine

Passed

On October 20, 2020, the Company accepted and passed the GMP compliance inspection and defect rectification review on Group A and Group C Meningococcal Conjugate Vaccine by the inspection team organized by Sichuan Medical Products Administration.


On October 22, 2020, the Company accepted and passed the on-site inspections on the Company’s renewal of Drug Manufacturing Certificate upon expiration of its validity by the inspection team organized by Sichuan Medical Products Administration.


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

October 20, 2020

Sichuan Medical Products Administration

GMP compliance inspection and defect rectification review on Group A and Group C Meningococcal Conjugate Vaccine

Passed

2

October 22, 2020

Sichuan Medical Products Administration

On-site inspections on the renewal of Drug Manufacturing Certificate upon expiration of its validity

Passed


On August 18, 2020, the Company accepted and passed the on-site inspection on the changes of the newly added Finished Products Warehouse 8 by the vaccine field inspector appointed by Sichuan Medical Products Administration.

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

August 18, 2020

Sichuan Medical Products Administration

On-site inspection on the changes of the newly added Finished Products Warehouse 8

Passed


On September 9, 2020, the Company accepted and passed the review on the production site rectification of the Company by the inspection team organized by Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring.


From September 28 to 29, 2020, the Company accepted and passed the inspection on the Company’s adverse drug reaction report and testing by the inspection team organized by Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring.

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

September 9, 2020

Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring

Review of production site rectification after national inspection and defect rectification

Passed

2

September 28 to 29, 2020

Sichuan Center for Food and Drug Evaluation, Inspection & Monitoring

Inspection on the Company’s adverse drug reaction report and testing

Passed

上一条:Inspection & Penalty下一条:Inspection & Penalty