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PFIZER SA DE CV

⚠️ Moderate Risk

FEI: 3031096598 • Texcoco • MEXICO

FEI

FEI Number

3031096598

📍

Location

Texcoco

🇲🇽

Country

MEXICO
🏢

Address

Texcoco De Mora Centro, , Texcoco, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/26/2024
Latest Refusal
8/26/2024
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
72.1×20%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
8/26/2024
60DPL99ADRENOCORTICAL STEROID N.E.C.
472NO ENGLISH
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PFIZER SA DE CV's FDA import refusal history?

PFIZER SA DE CV (FEI: 3031096598) has 1 FDA import refusal record(s) in our database, spanning from 8/26/2024 to 8/26/2024.

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 SA DE CV's FEI number is 3031096598.

What types of violations has PFIZER SA DE CV received?

PFIZER SA DE CV 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 PFIZER SA DE CV come from?

All FDA import refusal data for PFIZER SA DE CV 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.