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Pfizer Specialties

⚠️ Moderate Risk

FEI: 3005151781 • Lagos, Cross River State • NIGERIA

FEI

FEI Number

3005151781

📍

Location

Lagos, Cross River State

🇳🇬

Country

NIGERIA
🏢

Address

Churchgate Towers Asrpanic St, , Lagos, Cross River State, Nigeria

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
5
Unique Violations
11/15/2011
Latest Refusal
7/22/2005
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.2×10%
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).

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
11/15/2011
60XAK20NADOLOL (ANTI-ADRENERGIC)
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/22/2005
62CCA99ANTI-HYPERTENSIVE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pfizer Specialties's FDA import refusal history?

Pfizer Specialties (FEI: 3005151781) has 2 FDA import refusal record(s) in our database, spanning from 7/22/2005 to 11/15/2011.

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. Pfizer Specialties's FEI number is 3005151781.

What types of violations has Pfizer Specialties received?

Pfizer Specialties has been cited for 5 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 Specialties come from?

All FDA import refusal data for Pfizer Specialties 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.