GMP inspection findings clarification

Correspondence from Central Drugs Standard Control Organisation regarding CDSCO-2022-0093. Type: deficiency. Risk: low. Category: Administrative.

Correspondence ID
COR-293
Type
deficiency
Application
CDSCO-2022-0093
Authority
Central Drugs Standard Control Organisation
Category
Administrative
Risk
Low
Due Date
2025-01-08
Status
Overdue
Owner
Lieselotte van der Berg
Created
2022-07-01
Correspondence Body
Dear CDSCO Review Team, With reference to application CDSCO-2022-0093, we wish to address the following: [Detailed response body regarding deficiency: inadequate paediatric data justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_293_1.pdfdata_table_293.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.