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Beijing Able Institute Of Biomaterial

⚠️ Moderate Risk

FEI: 3007661382 • Daxing, Beijing • CHINA

FEI

FEI Number

3007661382

📍

Location

Daxing, Beijing

🇨🇳

Country

CHINA
🏢

Address

No 5 Yingtou Road, Yinghaizhen, Daxing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/10/2015
Latest Refusal
11/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

751×

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
11/10/2015
53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Beijing Able Institute Of Biomaterial's FDA import refusal history?

Beijing Able Institute Of Biomaterial (FEI: 3007661382) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2015 to 11/10/2015.

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. Beijing Able Institute Of Biomaterial's FEI number is 3007661382.

What types of violations has Beijing Able Institute Of Biomaterial received?

Beijing Able Institute Of Biomaterial 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 Beijing Able Institute Of Biomaterial come from?

All FDA import refusal data for Beijing Able Institute Of Biomaterial 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.