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Shanghai New Asiatic Pharmaceuticals CO, LTD

✅ Low Risk

FEI: 3003222233 • Shanghai, Unknown • CHINA

FEI

FEI Number

3003222233

📍

Location

Shanghai, Unknown

🇨🇳

Country

CHINA
🏢

Address

NO 6288 Shangchuan Road Pudong, , Shanghai, Unknown, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
3/23/2011
Latest Refusal
3/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
3/23/2011
65OCS15SUCCIMER (RADIOACTIVE AGENT - PART II)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Shanghai New Asiatic Pharmaceuticals CO, LTD's FDA import refusal history?

Shanghai New Asiatic Pharmaceuticals CO, LTD (FEI: 3003222233) has 1 FDA import refusal record(s) in our database, spanning from 3/23/2011 to 3/23/2011.

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. Shanghai New Asiatic Pharmaceuticals CO, LTD's FEI number is 3003222233.

What types of violations has Shanghai New Asiatic Pharmaceuticals CO, LTD received?

Shanghai New Asiatic Pharmaceuticals 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 Shanghai New Asiatic Pharmaceuticals CO, LTD come from?

All FDA import refusal data for Shanghai New Asiatic Pharmaceuticals 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.