GMP inspection findings clarification
Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0050. Type: commitment-request. Risk: low. Category: Quality.
Correspondence ID
COR-050
Type
commitment-request
Application
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
Low
Due Date
2025-05-01
Status
Open
Owner
Nadia Petrova
Created
2023-05-28
Correspondence Body
Dear MFDS Review Team,
With reference to application MFDS-2020-0050, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_50.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-01 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.