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Glaxo Smith Kline Phils Inc

✅ Low Risk

FEI: 3005410127 • Dakati City • PHILIPPINES

FEI

FEI Number

3005410127

📍

Location

Dakati City

🇵🇭
🏢

Address

2866 C Rocs Ave, , Dakati City, , Philippines

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
12/12/2005
Latest Refusal
12/12/2005
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
12/12/2005
62CCC99ANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Glaxo Smith Kline Phils Inc's FDA import refusal history?

Glaxo Smith Kline Phils Inc (FEI: 3005410127) has 1 FDA import refusal record(s) in our database, spanning from 12/12/2005 to 12/12/2005.

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. Glaxo Smith Kline Phils Inc's FEI number is 3005410127.

What types of violations has Glaxo Smith Kline Phils Inc received?

Glaxo Smith Kline Phils Inc 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 Glaxo Smith Kline Phils Inc come from?

All FDA import refusal data for Glaxo Smith Kline Phils Inc 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.