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Zhejiang Dingtai Pharmaceutical Co., Ltd

⚠️ Moderate Risk

FEI: 3011302639 • Jia Xing, Zhejiang • CHINA

FEI

FEI Number

3011302639

📍

Location

Jia Xing, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No. 1392 Huancheng South Road, Tongxiang, Jia Xing, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

36.2
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/11/2024
Latest Refusal
1/11/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
44.7×20%
Frequency
20.0×10%
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

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/11/2024
60LBD99ANALGESIC, N.E.C.
3280FRNMFGREG
Division of Northeast Imports (DNEI)
1/11/2024
60LBD99ANALGESIC, N.E.C.
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Zhejiang Dingtai Pharmaceutical Co., Ltd's FDA import refusal history?

Zhejiang Dingtai Pharmaceutical Co., Ltd (FEI: 3011302639) has 2 FDA import refusal record(s) in our database, spanning from 1/11/2024 to 1/11/2024.

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 Dingtai Pharmaceutical Co., Ltd's FEI number is 3011302639.

What types of violations has Zhejiang Dingtai Pharmaceutical Co., Ltd received?

Zhejiang Dingtai Pharmaceutical 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 Zhejiang Dingtai Pharmaceutical Co., Ltd come from?

All FDA import refusal data for Zhejiang Dingtai Pharmaceutical 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.