Meytel International Inc.
⚠️ Moderate Risk
FEI: 3003294336 • Montreal, QC • CANADA
FEI Number
3003294336
Location
Montreal, QC
Country
CANADAAddress
2650 Gouin Blv. W, , Montreal, QC, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2003 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 8/15/2003 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 8/15/2003 | 64HAS02GUAIFENESIN (EXPECTORANT) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA05ASPIRIN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60SAY99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 8/15/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 8/15/2003 | 60SAA99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 8/15/2003 | 60SAA99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 5/1/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60CAL51TETRAHYDROZOLINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 62UAV99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 62UBK11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60LAA05ASPIRIN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60LAA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 62GAB41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60LAA05ASPIRIN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60SAV99ANTACID, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 62GAB41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 63UAJ99DENTIN DESENSITIZER N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60BCA99ACIDIFIER N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/1/2003 | 60SAV99ANTACID, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Meytel International Inc.'s FDA import refusal history?
Meytel International Inc. (FEI: 3003294336) has 26 FDA import refusal record(s) in our database, spanning from 5/1/2003 to 8/15/2003.
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. Meytel International Inc.'s FEI number is 3003294336.
What types of violations has Meytel International Inc. received?
Meytel International Inc. 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 Meytel International Inc. come from?
All FDA import refusal data for Meytel International Inc. 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.