Pupa -Micys Co Spa
⚠️ Moderate Risk
FEI: 3002862393 • Casatenovo, Lecco • ITALY
FEI Number
3002862393
Location
Casatenovo, Lecco
Country
ITALYAddress
Via Alcide De Gasperi 22, , Casatenovo, Lecco, Italy
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
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).
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).
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.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2019 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/14/2019 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/14/2019 | 66BBL05CAFFEINE (STIMULANT) | Division of Southeast Imports (DSEI) | |
| 12/28/2011 | 66VIO99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 6/23/2003 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | New York District Office (NYK-DO) |
| 11/7/2002 | 53CC03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pupa -Micys Co Spa's FDA import refusal history?
Pupa -Micys Co Spa (FEI: 3002862393) has 6 FDA import refusal record(s) in our database, spanning from 11/7/2002 to 3/14/2019.
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. Pupa -Micys Co Spa's FEI number is 3002862393.
What types of violations has Pupa -Micys Co Spa received?
Pupa -Micys Co Spa 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 Pupa -Micys Co Spa come from?
All FDA import refusal data for Pupa -Micys Co Spa 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.