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Pfizer Asia Manufacturing Pte Ltd.

⚠️ Moderate Risk

FEI: 3003901862 • Singapore • SINGAPORE

FEI

FEI Number

3003901862

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

31 Tuas South Avenue 6, , Singapore, , Singapore

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/3/2010
Latest Refusal
8/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
8/3/2010
61NCS69GABAPENTIN (ANTI-DEPRESSANT)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Pfizer Asia Manufacturing Pte Ltd.'s FDA import refusal history?

Pfizer Asia Manufacturing Pte Ltd. (FEI: 3003901862) has 1 FDA import refusal record(s) in our database, spanning from 8/3/2010 to 8/3/2010.

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. Pfizer Asia Manufacturing Pte Ltd.'s FEI number is 3003901862.

What types of violations has Pfizer Asia Manufacturing Pte Ltd. received?

Pfizer Asia Manufacturing Pte 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 Pfizer Asia Manufacturing Pte Ltd. come from?

All FDA import refusal data for Pfizer Asia Manufacturing Pte 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.