McNeil AB
⚠️ Moderate Risk
FEI: 1000409186 • Helsingborg, Skane Lan • SWEDEN
FEI Number
1000409186
Location
Helsingborg, Skane Lan
Country
SWEDENAddress
Norrbroplatsen 2, , Helsingborg, Skane Lan, Sweden
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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2020 | 66BAY44NICOTINE DELIVERY SYSTEM | Division of West Coast Imports (DWCI) | |
| 12/30/2020 | 66BAY44NICOTINE DELIVERY SYSTEM | Division of West Coast Imports (DWCI) | |
| 10/5/2018 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/5/2018 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/27/2017 | 66BAL44NICOTINE DELIVERY SYSTEM | Division of Southeast Imports (DSEI) | |
| 6/24/2016 | 66BAQ44NICOTINE DELIVERY SYSTEM | Division of Northeast Imports (DNEI) | |
| 9/2/2009 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/13/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is McNeil AB's FDA import refusal history?
McNeil AB (FEI: 1000409186) has 8 FDA import refusal record(s) in our database, spanning from 4/13/2007 to 12/30/2020.
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. McNeil AB's FEI number is 1000409186.
What types of violations has McNeil AB received?
McNeil AB 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 McNeil AB come from?
All FDA import refusal data for McNeil AB 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.