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Gansu Cheezheng Industrial Group Co., Ltd.

⚠️ Moderate Risk

FEI: 3003731194 • Lanzhou • CHINA

FEI

FEI Number

3003731194

📍

Location

Lanzhou

🇨🇳

Country

CHINA
🏢

Address

105 Keji Street, , Lanzhou, , China

Moderate Risk

FDA Import Risk Assessment

35.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
5/19/2004
Latest Refusal
12/19/2002
Earliest Refusal

Score Breakdown

Violation Severity
72.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
14.1×10%
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

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
5/19/2004
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/19/2002
60LBY99ANALGESIC, N.E.C.
16DIRECTIONS
223FALSE
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Gansu Cheezheng Industrial Group Co., Ltd.'s FDA import refusal history?

Gansu Cheezheng Industrial Group Co., Ltd. (FEI: 3003731194) has 2 FDA import refusal record(s) in our database, spanning from 12/19/2002 to 5/19/2004.

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. Gansu Cheezheng Industrial Group Co., Ltd.'s FEI number is 3003731194.

What types of violations has Gansu Cheezheng Industrial Group Co., Ltd. received?

Gansu Cheezheng Industrial Group Co., Ltd. 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 Gansu Cheezheng Industrial Group Co., Ltd. come from?

All FDA import refusal data for Gansu Cheezheng Industrial Group Co., Ltd. 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.