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Pfizer Consumer Healthcare Limited

⚠️ Moderate Risk

FEI: 3008592133 • Berkshire • UNITED KINGDOM

FEI

FEI Number

3008592133

📍

Location

Berkshire

🇬🇧
🏢

Address

Vanwall Roadmaidenhead, , Berkshire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
2/28/2014
Latest Refusal
2/28/2014
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

23006×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

36816×

NCONTACTS

The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.

4826×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)
2/28/2014
54AEA99VITAMIN, N.E.C.
2300DIETARYLBL
3681NCONTACTS
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pfizer Consumer Healthcare Limited's FDA import refusal history?

Pfizer Consumer Healthcare Limited (FEI: 3008592133) has 6 FDA import refusal record(s) in our database, spanning from 2/28/2014 to 2/28/2014.

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 Consumer Healthcare Limited's FEI number is 3008592133.

What types of violations has Pfizer Consumer Healthcare Limited received?

Pfizer Consumer Healthcare Limited has been cited for 3 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 Consumer Healthcare Limited come from?

All FDA import refusal data for Pfizer Consumer Healthcare Limited 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.