GMP inspection findings clarification
Correspondence from Health Canada regarding HC-2024-0086. Type: question. Risk: low. Category: Clinical.
Correspondence ID
COR-086
Type
question
Application
Authority
Health Canada
Category
Clinical
Risk
Low
Due Date
2025-04-09
Status
In Progress
Owner
Aisha Okonkwo
Created
2023-01-17
Correspondence Body
Dear HC Review Team,
With reference to application HC-2024-0086, we wish to address the following:
[Detailed response body regarding query: container closure integrity study methodology]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.