GMP inspection findings clarification
Correspondence from Saudi Food and Drug Authority regarding SFDA-2023-0097. Type: query. Risk: medium. Category: Quality.
Correspondence ID
COR-097
Type
query
Application
Authority
Saudi Food and Drug Authority
Category
Quality
Risk
Medium
Due Date
2025-03-29
Status
Completed
Owner
Dmitri Volkov
Created
2023-08-07
Correspondence Body
Dear SFDA Review Team,
With reference to application SFDA-2023-0097, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_97_1.pdfdata_table_97.xlsx
Response Package
Response package assembled: RP-097