Information request: manufacturing process change justificat

Correspondence from Food and Drug Administration regarding FDA-2024-0001. Type: deficiency. Risk: medium. Category: Labeling.

Correspondence ID
COR-001
Type
deficiency
Application
FDA-2024-0001
Authority
Food and Drug Administration
Category
Labeling
Risk
Medium
Due Date
2025-02-24
Status
Completed
Owner
Dmitri Volkov
Created
2023-12-31
Correspondence Body
Dear FDA Review Team, With reference to application FDA-2024-0001, 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 Package
Response package assembled: RP-001