---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-016996"
form_type: "8-K"
ticker: "CRMD"
cik: "0001410098"
company_name: "CorMedix Inc."
filed_at: "2023-03-03T23:59:59+00:00"
generated_at: "2026-06-18T12:56:13.843397+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# CorMedix updates DefenCath NDA resubmission pathways; CMO 1 completes corrective actions

## Summary
- CMO 1 completed all corrective actions from FDA's June 2022 inspection; awaits FDA feedback on compliance status.
- Heparin API supplier updated DMF; FDA recently approved a supplement referencing same DMF, potentially removing warning letter barrier.
- Company plans to submit Type A meeting request by mid-March to seek FDA guidance on CMO 1 clearance and API 1 DMF use.
- Pathway #1 (CMO 1 + API 1) could be Class 1 (60-day review); Pathway #2 (CMO 1 + API 2) data expected mid-April, Class 2 (6-month).
- Pathway #3 (CMO 2 + API 2) data delayed to Q3 2023; remains backup strategy.

## SEC filing metadata
- accession: 0001213900-23-016996
- form_type: 8-K
- ticker: CRMD
- cik: 0001410098
- company_name: CorMedix Inc.
- filed_at: 2023-03-03T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1410098/000121390023016996/0001213900-23-016996-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1410098/000121390023016996/ea174602-8k_cormedix.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-016996
- JSON: https://secwatch.observer/filing/0001213900-23-016996.json
- Plain text: https://secwatch.observer/filing/0001213900-23-016996.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.