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Information Disclosure
Status of Inspections and Penalties
I. Acceptance of domestic drug regulatory inspections
|
Inspection time Time of Inspection |
Inspecting Unit Inspection Unit |
Inspection Type Type of Inspection |
Scope of Inspection Inspection Scope |
Test results The Result of Inspection |
|
June 15–18, 2020 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
Vaccine Inspection and Oversight |
23-valent pneumococcal polysaccharide vaccine |
On-site inspection passed. |
|
July 15–17, 2020 |
Beijing Municipal Drug Certification Management Center |
GMP Compliance Inspection |
23-valent pneumococcal polysaccharide vaccine, Measles–rubella combined attenuated live vaccine |
Announcement of the Beijing Municipal Drug Administration on the Results of Pharmaceutical GMP Compliance Inspections Announcement No. 14 of 2021: Passed GMP Compliance Inspection |
|
September 9–13, 2020 September 22–25, 2020 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
Lyophilized Haemophilus influenzae type b conjugate vaccine |
Obtained the drug registration certificate on June 1, 2021. |
|
September 27–29, 2020 |
Beijing Municipal Drug Certification Management Center |
Pre-Listing GMP Compliance Inspection |
Lyophilized Haemophilus influenzae type b conjugate vaccine |
Announcement of the Beijing Municipal Drug Administration on the Results of Pharmaceutical GMP Compliance Inspections Announcement No. 14 of 2021: Passed GMP Compliance Inspection |
|
January 26–30, 2021 March 15–18, 2021 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) |
Obtained the drug registration certificate on September 10, 2021. |
|
January 26–30, 2021 March 15–19, 2021 |
Beijing Municipal Drug Certification Management Center |
Pre-Listing GMP Compliance Inspection |
13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) |
On September 18, 2021, a notification of inspection results compliant with GMP standards was received. |
|
March 23–26, 2021 |
Beijing Municipal Drug Certification Management Center |
Pre-Listing GMP Compliance Inspection |
Adsorbed Diphtheria–Tetanus–Pertussis Combined Vaccine |
On August 12, 2021, a notification of inspection results compliant with GMP standards was received. |
|
July 26–28, 2021 |
National Medical Products Administration National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
acellular diphtheria–tetanus–pertussis and Haemophilus influenzae type b combination vaccine |
On-site inspection passed. |
|
September 7–9, 2021 |
Beijing Municipal Drug Certification Management Center |
GMP Compliance Inspection |
23-valent pneumococcal polysaccharide vaccine |
Announcement of the Beijing Municipal Drug Administration on the Results of Pharmaceutical GMP Compliance Inspections Notice No. 12 of 2022: Passed the Conformity Assessment |
|
March 14–18, 2022 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
Lyophilized Human Rabies Vaccine (Human Diploid Cell Line) |
Obtained the drug registration certificate on September 12, 2023. |
|
March 14–18, 2022 |
Beijing Municipal Drug Review and Inspection Center |
Pre-Listing GMP Compliance Inspection |
Lyophilized Human Rabies Vaccine (Human Diploid Cell Line) |
Notification of GMP-compliant inspection results dated September 27, 2023. |
|
August 10–12, 2022 |
Beijing Center for Adverse Drug Reaction Monitoring |
GVP Compliance Check |
Pharmacovigilance |
On-site inspection passed. |
|
September 5–8, 2022 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
Vaccine Inspection and Oversight |
13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) |
On-site inspection passed. |
|
September 26–30, 2022 |
Beijing Municipal Drug Review and Inspection Center |
GMP Compliance Inspection |
acellular diphtheria–tetanus–pertussis–Haemophilus influenzae type b combination vaccine, Haemophilus influenzae type b conjugate vaccine |
Announcement of the Beijing Municipal Drug Administration on the Results of Pharmaceutical GMP Compliance Inspections Notice No. 4 of 2023: Passed the conformity assessment. |
|
January 3–7, 2023 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
Live attenuated varicella vaccine |
Obtained the drug registration certificate on April 11, 2024. |
|
January 3–7, 2023 |
Beijing Municipal Drug Review and Inspection Center |
Pre-Listing GMP Compliance Inspection |
Live attenuated varicella vaccine |
On May 22, 2024, the inspection notice confirming compliance with pharmaceutical GMP standards was obtained. |
|
May 24–27, 2023 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Lyophilized Haemophilus influenzae type b conjugate vaccine, acellular diphtheria–tetanus–pertussis and Haemophilus influenzae type b combination vaccine |
On-site inspection passed. |
|
May 25–27, 2023 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Pharmacovigilance |
On-site inspection passed. |
|
September 25–26, 2023 |
Beijing Center for Adverse Drug Reaction Monitoring |
GVP Compliance Check |
Good Pharmacovigilance Practice Guidelines |
On December 4, 2023, an inspection opinion was obtained that complies with the pharmaceutical GVP standards. |
|
October 16–20, 2023 |
Beijing Municipal Drug Review and Inspection Center |
Annual Compliance Inspection |
Lyophilized Haemophilus influenzae type b conjugate vaccine, 13-valent pneumococcal polysaccharide conjugate vaccine (tetanus toxoid/diphtheria toxoid) |
On December 19, 2023, the inspection notice confirming compliance with pharmaceutical GMP standards was obtained. |
|
April 15–19, 2024 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
Adsorbed Diphtheria–Tetanus–Pertussis Combined Vaccine |
The approval notice for the supplementary drug application has been obtained; notice number: 2024B05184, approval date: November 11, 2024. |
|
April 15–19, 2024 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
acellular diphtheria–tetanus–pertussis and Haemophilus influenzae type b combination vaccine |
The approval notice for the supplementary drug application has been obtained; notice number: 2024B05183, approval date: November 11, 2024. |
|
April 15–19, 2024 |
Beijing Municipal Drug Review and Inspection Center |
GMP compliance inspections of pharmaceutical products conducted upon enterprise application, as well as annual GMP compliance inspections. |
Adsorbed acellular diphtheria–tetanus–pertussis combined vaccine, acellular diphtheria–tetanus–pertussis–Haemophilus influenzae type b combined vaccine |
A GMP compliance inspection notice has been obtained, with the following reference numbers: Jing Yao Jian Yao GMP [2024] No. 020028 and Jing Yao Jian Yao GMP [2024] No. 020351; approval date: January 10, 2025. |
|
July 25–28, 2024 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Lyophilized Human Rabies Vaccine (Human Diploid Cell Line) |
On-site inspection passed. |
|
August 12–16, 2024 |
Center for Drug and Food Review and Inspection, National Medical Products Administration |
On-site Inspection for Drug Registration |
Sabin-strain inactivated poliovirus vaccine (Vero cell) |
Obtained the drug registration certificate on September 9, 2025. |
|
August 12–16, 2024 October 23–25, 2024 |
Beijing Municipal Drug Review and Inspection Center |
Pre-Listing GMP Compliance Inspection |
Sabin-strain inactivated poliovirus vaccine (Vero cell) |
A notification of inspection confirming compliance with pharmaceutical GMP standards has been obtained. No.: Jingyaojian Yao GMP [2024] No. 020063; Approval Date: October 25, 2025 |
|
September 25–27, 2024 |
Beijing Center for Adverse Drug Reaction Monitoring |
GVP Compliance Check |
Good Pharmacovigilance Practice Guidelines |
The Notification of Compliance Inspection for Pharmaceutical GVP has been obtained. Reference Number: GVP[2024]020037 Approval Date: July 1, 2025 |
|
June 16–19, 2025 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Live attenuated varicella vaccine |
On-site inspection passed. |
|
September 1–2, 2025 |
Beijing Center for Adverse Drug Reaction Monitoring |
GVP Compliance Check |
Good Pharmacovigilance Practice Guidelines |
|
|
September 1–5, 2025 |
Beijing Municipal Drug Review and Inspection Center |
Pharmaceutical GMP Compliance Inspection |
Lyophilized Human Rabies Vaccine (Human Diploid Cell Line) |
A certificate of compliance with pharmaceutical GMP standards has been obtained; compliance number upon application: Jing Yao Jian Yao GMP {2025} 020094; approval date: December 5, 2025; annual compliance number: FHS2025005; approval date: December 19, 2025. |
|
September 15–19, 2025 |
National Medical Products Administration Inspection Center |
On-site Inspection for Drug Registration |
Adsorbed tetanus vaccine |
The drug has obtained a drug registration certificate, with the approval number: National Drug Approval No. S20260021, and the approval date: March 31, 2026. |
|
September 15–19, 2025; November 17; November 18 |
Beijing Municipal Drug Review and Inspection Center |
Pre‑marketing GMP Compliance Inspection of Pharmaceuticals |
Adsorbed tetanus vaccine |
The inspection notification certifying compliance with pharmaceutical GMP standards has been obtained, with the following details: No. Jing Yao Jian Yao GMP {2025} 020090; approval date: April 28, 2026. |
|
May 25–29, 2026 |
Beijing Municipal Drug Review and Inspection Center |
Pharmaceutical GMP Compliance Inspection |
23-valent pneumococcal polysaccharide vaccine |
On-site inspection passed. |
|
June 23–26, 2026 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Adsorbed acellular diphtheria–tetanus–pertussis combined vaccine, acellular diphtheria–tetanus–pertussis–Haemophilus influenzae type b combined vaccine |
On-site inspection passed. |
|
June 23–25, 2026 |
National Vaccine Inspection Center |
Vaccine Inspection and Oversight |
Pharmacovigilance |
On-site inspection passed. |
II. Acceptance of Foreign Drug Regulatory Inspections
|
Inspection time Time of Inspection |
Inspecting Unit Inspection Unit |
Inspection Type Type of Inspection |
Scope of Inspection Inspection Scope |
Test results The Result of Inspection |
|
January 12–16, 2026 |
Kazakhstan National Center for the Evaluation of Medicines and Medical Devices |
GMP inspection |
Adsorbed Diphtheria–Tetanus–Pertussis Combined Vaccine |
A GMP certificate for the adsorbed acellular diphtheria–tetanus–pertussis combined vaccine has been obtained in Kazakhstan, with certificate number 23-04-2926/OZ-I and approval date April 24, 2026. |
III. Acceptance of Penalties
None
Contact Information
Customer Service Hotline
4001899806
Phone number
010-59613600
Official Website
Company Address
No. 35 Simiao Road and No. 25 Tianfu Street, Daxing Biomedical Industry Base, Zhongguancun Science Park, Daxing District, Beijing
WeChat Official Account
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