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PFIZER LTD

⚠️ High Risk

FEI: 3019879928 • New Delhi • INDIA

FEI

FEI Number

3019879928

📍

Location

New Delhi

🇮🇳

Country

INDIA
🏢

Address

Besides Hyatt Regency B, , New Delhi, , India

High Risk

FDA Import Risk Assessment

52.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
12/28/2023
Latest Refusal
12/28/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
58.7×20%
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

751×

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).

Refusal History

DateProductViolationsDivision
12/28/2023
54YFF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PFIZER LTD's FDA import refusal history?

PFIZER LTD (FEI: 3019879928) has 1 FDA import refusal record(s) in our database, spanning from 12/28/2023 to 12/28/2023.

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 LTD's FEI number is 3019879928.

What types of violations has PFIZER LTD received?

PFIZER 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 LTD come from?

All FDA import refusal data for PFIZER 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.