Danso Gloria Mpere
⚠️ High Risk
FEI: 3008199043 • Burnsville, MN • UNITED STATES
FEI Number
3008199043
Location
Burnsville, MN
Country
UNITED STATESAddress
12521 Portland Ave., , Burnsville, MN, United States
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 4/8/2010 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Danso Gloria Mpere's FDA import refusal history?
Danso Gloria Mpere (FEI: 3008199043) has 9 FDA import refusal record(s) in our database, spanning from 4/8/2010 to 4/8/2010.
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. Danso Gloria Mpere's FEI number is 3008199043.
What types of violations has Danso Gloria Mpere received?
Danso Gloria Mpere has been cited for 2 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 Danso Gloria Mpere come from?
All FDA import refusal data for Danso Gloria Mpere 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.