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Procter And Gamble Company

⚠️ Moderate Risk

FEI: 3005041430 • Cincinnati, OH • UNITED STATES

FEI

FEI Number

3005041430

📍

Location

Cincinnati, OH

🇺🇸
🏢

Address

5289 Vine St, , Cincinnati, OH, United States

Moderate Risk

FDA Import Risk Assessment

32.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/21/2023
Latest Refusal
9/15/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
35.2×20%
Frequency
1.4×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
7/21/2023
61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL)
118NOT LISTED
Division of Northern Border Imports (DNBI)
9/15/2009
63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Procter And Gamble Company's FDA import refusal history?

Procter And Gamble Company (FEI: 3005041430) has 2 FDA import refusal record(s) in our database, spanning from 9/15/2009 to 7/21/2023.

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. Procter And Gamble Company's FEI number is 3005041430.

What types of violations has Procter And Gamble Company received?

Procter And Gamble Company 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 Procter And Gamble Company come from?

All FDA import refusal data for Procter And Gamble Company 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.