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Zhengzhou Minzhong Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3004819810 • Zhengzhou, Henan • CHINA

FEI

FEI Number

3004819810

📍

Location

Zhengzhou, Henan

🇨🇳

Country

CHINA
🏢

Address

Intersection Of Sigangliandong Ave And Zhengshang Rd, , Zhengzhou, Henan, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
7/29/2003
Latest Refusal
6/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
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

162×

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.

28802×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

3362×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
7/29/2003
56KYY70RIFAMPIN
16DIRECTIONS
2880RXCOMPOUND
336INCONSPICU
Detroit District Office (DET-DO)
6/16/2003
56KYY70RIFAMPIN
16DIRECTIONS
2880RXCOMPOUND
336INCONSPICU
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Zhengzhou Minzhong Pharmaceutical Co., Ltd.'s FDA import refusal history?

Zhengzhou Minzhong Pharmaceutical Co., Ltd. (FEI: 3004819810) has 2 FDA import refusal record(s) in our database, spanning from 6/16/2003 to 7/29/2003.

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. Zhengzhou Minzhong Pharmaceutical Co., Ltd.'s FEI number is 3004819810.

What types of violations has Zhengzhou Minzhong Pharmaceutical Co., Ltd. received?

Zhengzhou Minzhong Pharmaceutical Co., Ltd. has been cited for 3 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 Zhengzhou Minzhong Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Zhengzhou Minzhong 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.