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Zhejiang Yongan Ga

✅ Low Risk

FEI: 3008873585 • Hangzhan • CHINA

FEI

FEI Number

3008873585

📍

Location

Hangzhan

🇨🇳

Country

CHINA
🏢

Address

Genshan Eastem Rd, , Hangzhan, , China

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
4
Unique Violations
6/11/2012
Latest Refusal
6/11/2012
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
6/11/2012
55RY50CALCIUM STEARATE (PHARMACEUTIC NECESSITY - TABLET LUBRICANT)
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
336INCONSPICU
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Zhejiang Yongan Ga's FDA import refusal history?

Zhejiang Yongan Ga (FEI: 3008873585) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2012 to 6/11/2012.

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. Zhejiang Yongan Ga's FEI number is 3008873585.

What types of violations has Zhejiang Yongan Ga received?

Zhejiang Yongan Ga has been cited for 4 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 Zhejiang Yongan Ga come from?

All FDA import refusal data for Zhejiang Yongan Ga 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.