---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-050197"
form_type: "8-K"
ticker: "ICCC"
cik: "0000811641"
company_name: "IMMUCELL CORP /DE/"
filed_at: "2024-06-06T23:59:59+00:00"
generated_at: "2026-06-01T06:06:15.221053+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# ImmuCell provides Re-Tain® FDA update; NADA submission after contract manufacturer clearance

## Summary
- Received FDA Incomplete Letter on CMC Technical Section for Re-Tain®; fourth submission prepared.
- ImmuCell's drug substance facility inspection cleared; contract manufacturer responses due by end of June 2024.
- Anticipates submitting Non-Administrative NADA with up to 180-day review, possibly shorter.
- Targets product expiration dating between Q2 2025 and Q1 2026, subject to FDA approval.

## SEC filing metadata
- accession: 0001213900-24-050197
- form_type: 8-K
- ticker: ICCC
- cik: 0000811641
- company_name: IMMUCELL CORP /DE/
- filed_at: 2024-06-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/0001213900-24-050197-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/811641/000121390024050197/ea0207422-8k_immucell.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-050197
- JSON: https://secwatch.observer/filing/0001213900-24-050197.json
- Plain text: https://secwatch.observer/filing/0001213900-24-050197.txt

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