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HC Biologics LLC

⚠️ High Risk

FEI: 3012069716 • Miami, FL • UNITED STATES

FEI

FEI Number

3012069716

📍

Location

Miami, FL

🇺🇸
🏢

Address

1221 Brickell Ave Ste 900 Pmb 922, , Miami, FL, United States

High Risk

FDA Import Risk Assessment

59.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
11/3/2025
Latest Refusal
11/3/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
96.2×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

4781×

TISSUE

This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.

Refusal History

DateProductViolationsDivision
11/3/2025
57JH03BONE
478TISSUE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HC Biologics LLC's FDA import refusal history?

HC Biologics LLC (FEI: 3012069716) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2025 to 11/3/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. HC Biologics LLC's FEI number is 3012069716.

What types of violations has HC Biologics LLC received?

HC Biologics LLC has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about HC Biologics LLC come from?

All FDA import refusal data for HC Biologics LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.