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Goldshield Pharmaceutical Ltd

⚠️ Moderate Risk

FEI: 3003609330 • Croydon, CRY • UNITED KINGDOM

FEI

FEI Number

3003609330

📍

Location

Croydon, CRY

🇬🇧
🏢

Address

12-16 Addiscombe Rd, , Croydon, CRY, United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/30/2012
Latest Refusal
1/20/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/30/2012
66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/20/2012
62GCY41IBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Goldshield Pharmaceutical Ltd's FDA import refusal history?

Goldshield Pharmaceutical Ltd (FEI: 3003609330) has 2 FDA import refusal record(s) in our database, spanning from 1/20/2012 to 3/30/2012.

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. Goldshield Pharmaceutical Ltd's FEI number is 3003609330.

What types of violations has Goldshield Pharmaceutical Ltd received?

Goldshield Pharmaceutical 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 Goldshield Pharmaceutical Ltd come from?

All FDA import refusal data for Goldshield Pharmaceutical 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.