ImportRefusal LogoImportRefusal

Shantou Great Impression Health Product Co., Ltd.

⚠️ Moderate Risk

FEI: 3004347862 • Shantoushi, Yandongsheng • CHINA

FEI

FEI Number

3004347862

📍

Location

Shantoushi, Yandongsheng

🇨🇳

Country

CHINA
🏢

Address

Great Impression Industrial Base, Shalong Town, Chaoyang, Shantoushi, Yandongsheng, 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
2
Unique Violations
11/9/2004
Latest Refusal
11/9/2004
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

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).

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
11/9/2004
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shantou Great Impression Health Product Co., Ltd.'s FDA import refusal history?

Shantou Great Impression Health Product Co., Ltd. (FEI: 3004347862) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2004 to 11/9/2004.

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. Shantou Great Impression Health Product Co., Ltd.'s FEI number is 3004347862.

What types of violations has Shantou Great Impression Health Product Co., Ltd. received?

Shantou Great Impression Health Product Co., Ltd. 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 Shantou Great Impression Health Product Co., Ltd. come from?

All FDA import refusal data for Shantou Great Impression Health Product 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.