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Qingdao Panglim Apparel Co., Ltd.

⚠️ Moderate Risk

FEI: 3004155617 • Qingdao • CHINA

FEI

FEI Number

3004155617

📍

Location

Qingdao

🇨🇳

Country

CHINA
🏢

Address

Madian Industrial Area, , Qingdao, , China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/11/2006
Latest Refusal
4/11/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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.

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
4/11/2006
64RCS99HORMONE N.E.C.
16DIRECTIONS
75UNAPPROVED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Qingdao Panglim Apparel Co., Ltd.'s FDA import refusal history?

Qingdao Panglim Apparel Co., Ltd. (FEI: 3004155617) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2006 to 4/11/2006.

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. Qingdao Panglim Apparel Co., Ltd.'s FEI number is 3004155617.

What types of violations has Qingdao Panglim Apparel Co., Ltd. received?

Qingdao Panglim Apparel 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 Qingdao Panglim Apparel Co., Ltd. come from?

All FDA import refusal data for Qingdao Panglim Apparel 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.