GMP inspection findings clarification
Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0013. Type: information-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-313
Type
information-request
Application
Authority
Central Drugs Standard Control Organisation
Category
Labeling
Risk
Medium
Due Date
2024-12-05
Status
In Progress
Owner
Marcus Webb
Created
2023-01-07
Correspondence Body
Dear CDSCO Review Team,
With reference to application CDSCO-2022-0013, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_313.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.