Laboratoires Abbott Cie
⚠️ High Risk
FEI: 3011071184 • Saint-Laurent, Quebec • CANADA
FEI Number
3011071184
Location
Saint-Laurent, Quebec
Country
CANADAAddress
8625 Rte Transcanadienne, , Saint-Laurent, Quebec, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/8/2024 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2012 | 66JQA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 1/12/2012 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/16/2005 | 66JIY99THYROID HORMONE N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 8/26/2003 | 62TCE02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/14/2003 | 79MUGSOLUTION, SALINE (WOUND DRESSING) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoires Abbott Cie's FDA import refusal history?
Laboratoires Abbott Cie (FEI: 3011071184) has 6 FDA import refusal record(s) in our database, spanning from 8/14/2003 to 7/8/2024.
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. Laboratoires Abbott Cie's FEI number is 3011071184.
What types of violations has Laboratoires Abbott Cie received?
Laboratoires Abbott Cie 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 Laboratoires Abbott Cie come from?
All FDA import refusal data for Laboratoires Abbott Cie 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.