Procter Gamble
⚠️ Moderate Risk
FEI: 1000339384 • Nenagh, Tipperary • IRELAND
FEI Number
1000339384
Location
Nenagh, Tipperary
Country
IRELANDAddress
Gortlandroe Industrial Estate, , Nenagh, Tipperary, Ireland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/2/2014 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/7/2014 | 76JESFLOSS, DENTAL | Florida District Office (FLA-DO) | |
| 1/7/2014 | 76EFWTOOTHBRUSH, MANUAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Procter Gamble's FDA import refusal history?
Procter Gamble (FEI: 1000339384) has 3 FDA import refusal record(s) in our database, spanning from 1/7/2014 to 4/2/2014.
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's FEI number is 1000339384.
What types of violations has Procter Gamble received?
Procter Gamble has been cited for 4 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 come from?
All FDA import refusal data for Procter 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.