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Yangzhou Baokang Chemical Co., Ltd.

⚠️ Moderate Risk

FEI: 3008914957 • Jiandu City, Jiangsu • CHINA

FEI

FEI Number

3008914957

📍

Location

Jiandu City, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Franchuan Chemical Park, , Jiandu City, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/1/2011
Latest Refusal
6/1/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

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.

Refusal History

DateProductViolationsDivision
6/1/2011
54AFS20MENADIONE (VITAMIN)
118NOT LISTED
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Yangzhou Baokang Chemical Co., Ltd.'s FDA import refusal history?

Yangzhou Baokang Chemical Co., Ltd. (FEI: 3008914957) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2011 to 6/1/2011.

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. Yangzhou Baokang Chemical Co., Ltd.'s FEI number is 3008914957.

What types of violations has Yangzhou Baokang Chemical Co., Ltd. received?

Yangzhou Baokang Chemical 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 Yangzhou Baokang Chemical Co., Ltd. come from?

All FDA import refusal data for Yangzhou Baokang Chemical 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.