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Sinopharm Weiqida Pharmaceutical Co. Ltd.

⚠️ Moderate Risk

FEI: 3010166430 • Datong, Shaanxi • CHINA

FEI

FEI Number

3010166430

📍

Location

Datong, Shaanxi

🇨🇳

Country

CHINA
🏢

Address

Pharmaceutical Industrial Park, Economic & Technological Development Zone, Datong, Shaanxi, China

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/2/2013
Latest Refusal
8/2/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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
8/2/2013
56BDT03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
Cincinnati District Office (CIN-DO)
8/2/2013
56BCT03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Sinopharm Weiqida Pharmaceutical Co. Ltd.'s FDA import refusal history?

Sinopharm Weiqida Pharmaceutical Co. Ltd. (FEI: 3010166430) has 2 FDA import refusal record(s) in our database, spanning from 8/2/2013 to 8/2/2013.

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. Sinopharm Weiqida Pharmaceutical Co. Ltd.'s FEI number is 3010166430.

What types of violations has Sinopharm Weiqida Pharmaceutical Co. Ltd. received?

Sinopharm Weiqida Pharmaceutical 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 Sinopharm Weiqida Pharmaceutical Co. Ltd. come from?

All FDA import refusal data for Sinopharm Weiqida 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.