Oui Pack
⚠️ Moderate Risk
FEI: 3004060954 • Bois De Filion, ONTARIO • CANADA
FEI Number
3004060954
Location
Bois De Filion, ONTARIO
Country
CANADAAddress
870 Industriel, , Bois De Filion, ONTARIO, Canada
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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2003 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 4/17/2003 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 12/11/2001 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Oui Pack's FDA import refusal history?
Oui Pack (FEI: 3004060954) has 12 FDA import refusal record(s) in our database, spanning from 12/11/2001 to 4/17/2003.
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. Oui Pack's FEI number is 3004060954.
What types of violations has Oui Pack received?
Oui Pack has been cited for 6 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 Oui Pack come from?
All FDA import refusal data for Oui Pack 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.