Procter & Gamble International O
⚠️ Moderate Risk
FEI: 3009146659 • Petit-Lancy, Geneva • SWITZERLAND
FEI Number
3009146659
Location
Petit-Lancy, Geneva
Country
SWITZERLANDAddress
route de Saint-Georges 47, , Petit-Lancy, Geneva, Switzerland
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2006 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 3/23/2006 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 3/23/2006 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Procter & Gamble International O's FDA import refusal history?
Procter & Gamble International O (FEI: 3009146659) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2006 to 11/14/2006.
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 International O's FEI number is 3009146659.
What types of violations has Procter & Gamble International O received?
Procter & Gamble International O 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 Procter & Gamble International O come from?
All FDA import refusal data for Procter & Gamble International O 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.