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HaiYang City ZiCheng Packing Products Co.,Ltd.

⚠️ Moderate Risk

FEI: 3010166272 • Yantai, Shandong • CHINA

FEI

FEI Number

3010166272

📍

Location

Yantai, Shandong

🇨🇳

Country

CHINA
🏢

Address

Zhonghoucun, Haiyang, Yantai, Shandong, China

Moderate Risk

FDA Import Risk Assessment

47.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
2/19/2014
Latest Refusal
1/4/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
35.5×10%
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

754×

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
2/19/2014
62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)
2/19/2014
62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)
2/19/2014
62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)
1/4/2013
62FAK23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is HaiYang City ZiCheng Packing Products Co.,Ltd.'s FDA import refusal history?

HaiYang City ZiCheng Packing Products Co.,Ltd. (FEI: 3010166272) has 4 FDA import refusal record(s) in our database, spanning from 1/4/2013 to 2/19/2014.

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. HaiYang City ZiCheng Packing Products Co.,Ltd.'s FEI number is 3010166272.

What types of violations has HaiYang City ZiCheng Packing Products Co.,Ltd. received?

HaiYang City ZiCheng Packing Products Co.,Ltd. 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 HaiYang City ZiCheng Packing Products Co.,Ltd. come from?

All FDA import refusal data for HaiYang City ZiCheng Packing Products 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.