Minerva Corporation
⚠️ Moderate Risk
FEI: 3003806817 • London • UNITED KINGDOM
FEI Number
3003806817
Location
London
Country
UNITED KINGDOMAddress
10 Gloucester, , London, , United Kingdom
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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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).
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.
SACCHARIN
The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2002 | 45TF01SACCHARIN, NON-NUTRITIVE SWEETENERS | 487SACCHARIN | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 53FC01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 336INCONSPICU | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 61WCF45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 62UDB08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 64LCJ60TRIAMCINOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/28/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Minerva Corporation's FDA import refusal history?
Minerva Corporation (FEI: 3003806817) has 16 FDA import refusal record(s) in our database, spanning from 10/28/2002 to 10/28/2002.
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. Minerva Corporation's FEI number is 3003806817.
What types of violations has Minerva Corporation received?
Minerva Corporation has been cited for 6 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 Minerva Corporation come from?
All FDA import refusal data for Minerva Corporation 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.