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The Procter & Gamble Co./The Gillette Company

⚠️ Moderate Risk

FEI: 1216894 • Cincinnati, OH • UNITED STATES

FEI

FEI Number

1216894

📍

Location

Cincinnati, OH

🇺🇸
🏢

Address

2 Procter And Gamble Plz, , Cincinnati, OH, United States

Moderate Risk

FDA Import Risk Assessment

31.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/28/2018
Latest Refusal
3/9/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.6×10%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
11/28/2018
85HEBTAMPON, MENSTRUAL, UNSCENTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)
3/9/2011
62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
27DRUG GMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is The Procter & Gamble Co./The Gillette Company's FDA import refusal history?

The Procter & Gamble Co./The Gillette Company (FEI: 1216894) has 2 FDA import refusal record(s) in our database, spanning from 3/9/2011 to 11/28/2018.

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. The Procter & Gamble Co./The Gillette Company's FEI number is 1216894.

What types of violations has The Procter & Gamble Co./The Gillette Company received?

The Procter & Gamble Co./The Gillette Company 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 The Procter & Gamble Co./The Gillette Company come from?

All FDA import refusal data for The Procter & Gamble Co./The Gillette 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.