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Proctor & Gamble

Low Risk

FEI: 3002459081 • Cincinnati, OH • UNITED STATES

FEI

FEI Number

3002459081

📍

Location

Cincinnati, OH

🇺🇸
🏢

Address

630 Main St, , Cincinnati, OH, United States

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
3/4/2002
Latest Refusal
3/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1181×

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).

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
3/4/2002
63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
336INCONSPICU
473LABELING
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Proctor & Gamble's FDA import refusal history?

Proctor & Gamble (FEI: 3002459081) has 1 FDA import refusal record(s) in our database, spanning from 3/4/2002 to 3/4/2002.

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. Proctor & Gamble's FEI number is 3002459081.

What types of violations has Proctor & Gamble received?

Proctor & Gamble 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 Proctor & Gamble come from?

All FDA import refusal data for Proctor & Gamble 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.