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Firstar Healthcare Company Limited (Guangzhou)

⚠️ Moderate Risk

FEI: 3003887292 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3003887292

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Bldg 2 Hq Room 901, 2 Tian An High-Tech, Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/12/2006
Latest Refusal
6/12/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
6/12/2006
79LRRKIT, FIRST AID
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Firstar Healthcare Company Limited (Guangzhou)'s FDA import refusal history?

Firstar Healthcare Company Limited (Guangzhou) (FEI: 3003887292) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2006 to 6/12/2006.

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. Firstar Healthcare Company Limited (Guangzhou)'s FEI number is 3003887292.

What types of violations has Firstar Healthcare Company Limited (Guangzhou) received?

Firstar Healthcare Company Limited (Guangzhou) 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 Firstar Healthcare Company Limited (Guangzhou) come from?

All FDA import refusal data for Firstar Healthcare Company Limited (Guangzhou) 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.