GMP inspection findings clarification
Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0077. Type: question. Risk: medium. Category: Quality.
Correspondence ID
COR-377
Type
question
Application
Authority
Saudi Food and Drug Authority
Category
Quality
Risk
Medium
Due Date
2025-01-22
Status
Open
Owner
Sarah Chen
Created
2023-09-10
Correspondence Body
Dear SFDA Review Team,
With reference to application SFDA-2023-0077, 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_377.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.