Beauty International Sylwia Michno
⚠️ Moderate Risk
FEI: 3011105145 • Rudawa, Malopolskie • POLAND
FEI Number
3011105145
Location
Rudawa, Malopolskie
Country
POLANDAddress
Mlynka 58, , Rudawa, 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2021 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) | |
| 4/22/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/22/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beauty International Sylwia Michno's FDA import refusal history?
Beauty International Sylwia Michno (FEI: 3011105145) has 22 FDA import refusal record(s) in our database, spanning from 4/22/2016 to 3/16/2021.
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. Beauty International Sylwia Michno's FEI number is 3011105145.
What types of violations has Beauty International Sylwia Michno received?
Beauty International Sylwia Michno has been cited for 5 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 Beauty International Sylwia Michno come from?
All FDA import refusal data for Beauty International Sylwia Michno 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.