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Procter & Gamble Co

⚠️ Moderate Risk

FEI: 3001782565 • Cincinnati, OH • UNITED STATES

FEI

FEI Number

3001782565

📍

Location

Cincinnati, OH

🇺🇸
🏢

Address

Distributing Co, PO Box 5577, Cincinnati, OH, United States

Moderate Risk

FDA Import Risk Assessment

48.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
9/27/2011
Latest Refusal
9/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
86.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

754×

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).

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
9/27/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
Florida District Office (FLA-DO)
9/27/2011
62WAY05ZIRCONIUM
75UNAPPROVED
Florida District Office (FLA-DO)
9/27/2011
62WAY05ZIRCONIUM
75UNAPPROVED
Florida District Office (FLA-DO)
9/27/2011
62WAY05ZIRCONIUM
75UNAPPROVED
Florida District Office (FLA-DO)
9/27/2011
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Procter & Gamble Co's FDA import refusal history?

Procter & Gamble Co (FEI: 3001782565) has 5 FDA import refusal record(s) in our database, spanning from 9/27/2011 to 9/27/2011.

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. Procter & Gamble Co's FEI number is 3001782565.

What types of violations has Procter & Gamble Co received?

Procter & Gamble Co 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 Procter & Gamble Co come from?

All FDA import refusal data for Procter & Gamble Co 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.