Sigma-Aldrich Ireland Ltd.
⚠️ Moderate Risk
FEI: 3002807302 • Arklow, Co. WICKLOW • IRELAND
FEI Number
3002807302
Location
Arklow, Co. WICKLOW
Country
IRELANDAddress
County Wicklow, Vale Road, Arklow, Co. WICKLOW, Ireland
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
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.
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).
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 |
|---|---|---|---|
| 7/12/2017 | 61XAS21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | Division of Northern Border Imports (DNBI) | |
| 2/24/2014 | 68JCS20TRANQUILIZER/ATARAXIC USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 5/12/2010 | 61XAS04BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 3/1/2010 | 61XAS04BROMPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | Chicago District Office (CHI-DO) | |
| 2/23/2005 | 61XAS21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 2/23/2005 | 61XAS21DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/23/2004 | 61NDS11CLOMIPRAMINE HCL (ANTI-DEPRESSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/2/2002 | 61NDS11CLOMIPRAMINE HCL (ANTI-DEPRESSANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sigma-Aldrich Ireland Ltd.'s FDA import refusal history?
Sigma-Aldrich Ireland Ltd. (FEI: 3002807302) has 8 FDA import refusal record(s) in our database, spanning from 1/2/2002 to 7/12/2017.
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. Sigma-Aldrich Ireland Ltd.'s FEI number is 3002807302.
What types of violations has Sigma-Aldrich Ireland Ltd. received?
Sigma-Aldrich Ireland Ltd. 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 Sigma-Aldrich Ireland Ltd. come from?
All FDA import refusal data for Sigma-Aldrich Ireland Ltd. 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.