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Allmed Medical Products Co., Ltd. (Dong Guan Factory)

⚠️ High Risk

FEI: 3004130013 • Dong Guan, Guangdong Prov. • CHINA

FEI

FEI Number

3004130013

📍

Location

Dong Guan, Guangdong Prov.

🇨🇳

Country

CHINA
🏢

Address

Of Tianmei Industry Zone, Huang Jiang Town, Dong Guan, Guangdong Prov., China

High Risk

FDA Import Risk Assessment

50.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
2/26/2013
Latest Refusal
2/22/2013
Earliest Refusal

Score Breakdown

Violation Severity
92.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

784×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

3041×

STERILITY

The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.

Refusal History

DateProductViolationsDivision
2/26/2013
79EFQSPONGE, GAUZE
304STERILITY
Southwest Import District Office (SWI-DO)
2/22/2013
79EFQSPONGE, GAUZE
78STERILITY
Southwest Import District Office (SWI-DO)
2/22/2013
79EFQSPONGE, GAUZE
78STERILITY
Southwest Import District Office (SWI-DO)
2/22/2013
79EFQSPONGE, GAUZE
78STERILITY
Southwest Import District Office (SWI-DO)
2/22/2013
79EFQSPONGE, GAUZE
78STERILITY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Allmed Medical Products Co., Ltd. (Dong Guan Factory)'s FDA import refusal history?

Allmed Medical Products Co., Ltd. (Dong Guan Factory) (FEI: 3004130013) has 5 FDA import refusal record(s) in our database, spanning from 2/22/2013 to 2/26/2013.

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. Allmed Medical Products Co., Ltd. (Dong Guan Factory)'s FEI number is 3004130013.

What types of violations has Allmed Medical Products Co., Ltd. (Dong Guan Factory) received?

Allmed Medical Products Co., Ltd. (Dong Guan Factory) has been cited for 2 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 Allmed Medical Products Co., Ltd. (Dong Guan Factory) come from?

All FDA import refusal data for Allmed Medical Products Co., Ltd. (Dong Guan Factory) 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.