Laboratoire Schmidt-Nagel Inc.
⚠️ Moderate Risk
FEI: 3008740602 • Quebec, Quebec • CANADA
FEI Number
3008740602
Location
Quebec, Quebec
Country
CANADAAddress
20330 Henri-Bourassa Blvd, , Quebec, Quebec, 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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2022 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/11/2019 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/11/2019 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/11/2019 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/16/2011 | 54YEL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratoire Schmidt-Nagel Inc.'s FDA import refusal history?
Laboratoire Schmidt-Nagel Inc. (FEI: 3008740602) has 5 FDA import refusal record(s) in our database, spanning from 8/16/2011 to 4/22/2022.
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. Laboratoire Schmidt-Nagel Inc.'s FEI number is 3008740602.
What types of violations has Laboratoire Schmidt-Nagel Inc. received?
Laboratoire Schmidt-Nagel Inc. 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 Laboratoire Schmidt-Nagel Inc. come from?
All FDA import refusal data for Laboratoire Schmidt-Nagel 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.