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Procter & Gamble Co

⚠️ Moderate Risk

FEI: 1000069026 • Cincinnati, OH • UNITED STATES

FEI

FEI Number

1000069026

📍

Location

Cincinnati, OH

🇺🇸
🏢

Address

4530 Este Ave, , Cincinnati, OH, United States

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/17/2003
Latest Refusal
3/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

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.

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
3/17/2003
63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
336INCONSPICU
473LABELING
75UNAPPROVED
Detroit District Office (DET-DO)

Frequently Asked Questions

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

Procter & Gamble Co (FEI: 1000069026) has 1 FDA import refusal record(s) in our database, spanning from 3/17/2003 to 3/17/2003.

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 1000069026.

What types of violations has Procter & Gamble Co received?

Procter & Gamble Co 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 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.