Deficiency letter: missing stability data for 40°C condition
Correspondence from COFEPRIS regarding COFEPRIS-2021-0014. Type: information-request. Risk: medium. Category: Quality.
Correspondence ID
COR-014
Type
information-request
Application
Authority
COFEPRIS
Category
Quality
Risk
Medium
Due Date
2025-04-22
Status
Draft
Owner
Aisha Okonkwo
Created
2023-01-31
Correspondence Body
Dear COFEPRIS Review Team,
With reference to application COFEPRIS-2021-0014, 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 Assembly
Draft Response Actions:
Response deadline: 2025-04-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.