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Beecham Pakistan ( Private ) Ltd

⚠️ Moderate Risk

FEI: 3003963960 • Karachi • PAKISTAN

FEI

FEI Number

3003963960

📍

Location

Karachi

🇵🇰

Country

PAKISTAN
🏢

Address

94-Deh Landhi, , Karachi, , Pakistan

Moderate Risk

FDA Import Risk Assessment

33.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
7/8/2006
Latest Refusal
5/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
9.5×10%
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

1182×

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).

751×

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
7/8/2006
60SBZ99ANTACID, N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
7/8/2006
60SBZ99ANTACID, N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
5/14/2003
65RBR18SODIUM BICARBONATE (REPLENISHER)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Beecham Pakistan ( Private ) Ltd's FDA import refusal history?

Beecham Pakistan ( Private ) Ltd (FEI: 3003963960) has 3 FDA import refusal record(s) in our database, spanning from 5/14/2003 to 7/8/2006.

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. Beecham Pakistan ( Private ) Ltd's FEI number is 3003963960.

What types of violations has Beecham Pakistan ( Private ) Ltd received?

Beecham Pakistan ( Private ) 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 Beecham Pakistan ( Private ) Ltd come from?

All FDA import refusal data for Beecham Pakistan ( Private ) 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.