Mcr Corporation Janina Mincer
⚠️ Moderate Risk
FEI: 3005098895 • Michalowice, Malopolskie • POLAND
FEI Number
3005098895
Location
Michalowice, Malopolskie
Country
POLANDAddress
Ul Korcluszki 37, , Michalowice, Malopolskie, Poland
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 473LABELING | Atlanta District Office (ATL-DO) |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 7/30/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 5/15/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 5/15/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Mcr Corporation Janina Mincer's FDA import refusal history?
Mcr Corporation Janina Mincer (FEI: 3005098895) has 6 FDA import refusal record(s) in our database, spanning from 5/15/2015 to 7/30/2015.
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. Mcr Corporation Janina Mincer's FEI number is 3005098895.
What types of violations has Mcr Corporation Janina Mincer received?
Mcr Corporation Janina Mincer 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 Mcr Corporation Janina Mincer come from?
All FDA import refusal data for Mcr Corporation Janina Mincer 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.