Mcewen Laboratories Limited
⚠️ High Risk
FEI: 3001190779 • Reading, WBK • UNITED KINGDOM
FEI Number
3001190779
Location
Reading, WBK
Country
UNITED KINGDOMAddress
12 Horseshoe Park, , Reading, WBK, United Kingdom
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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2002 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2002 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/2/2002 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/14/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 8/14/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/12/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/12/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/12/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/12/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/12/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 6/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/16/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/10/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/3/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/3/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/1/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/1/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 5/1/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 4/8/2002 | 57GB01ALLERGENIC EXTRACTS, NON-STANDARDIZED | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 4/3/2002 | 57GF01ALLERGENIC EXTRACTS, NON-STANDARDIZED | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 4/3/2002 | 64EAY99ENZYME N.E.C. | 27DRUG GMPS | New Orleans District Office (NOL-DO) |
| 4/1/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 4/1/2002 | 57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | New Orleans District Office (NOL-DO) |
| 12/20/2001 | 57GI01ALLERGENIC EXTRACTS, NON-STANDARDIZED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mcewen Laboratories Limited's FDA import refusal history?
Mcewen Laboratories Limited (FEI: 3001190779) has 32 FDA import refusal record(s) in our database, spanning from 12/20/2001 to 10/2/2002.
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. Mcewen Laboratories Limited's FEI number is 3001190779.
What types of violations has Mcewen Laboratories Limited received?
Mcewen Laboratories Limited 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 Mcewen Laboratories Limited come from?
All FDA import refusal data for Mcewen Laboratories Limited 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.