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JUSTIN BIOTECH CO

⚠️ Moderate Risk

FEI: 3038156809 • Jining City • CHINA

FEI

FEI Number

3038156809

📍

Location

Jining City

🇨🇳

Country

CHINA
🏢

Address

Na 6 Th Floor, No. 601-3, Jining City, , China

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
3
Unique Violations
6/16/2025
Latest Refusal
6/16/2025
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
73.7×20%
Frequency
20.0×10%
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

22802×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

4832×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/16/2025
56FIY99PEPTIDE N.E.C.
2280DIRSEXMPT
483DRUG NAME
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/16/2025
56FIY99PEPTIDE N.E.C.
2280DIRSEXMPT
483DRUG NAME
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JUSTIN BIOTECH CO's FDA import refusal history?

JUSTIN BIOTECH CO (FEI: 3038156809) has 2 FDA import refusal record(s) in our database, spanning from 6/16/2025 to 6/16/2025.

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. JUSTIN BIOTECH CO's FEI number is 3038156809.

What types of violations has JUSTIN BIOTECH CO received?

JUSTIN BIOTECH CO has been cited for 3 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 JUSTIN BIOTECH CO come from?

All FDA import refusal data for JUSTIN BIOTECH CO 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.