Tecnocosmesi S.p.A.
⚠️ Moderate Risk
FEI: 3004577686 • Massalengo, Lodi • ITALY
FEI Number
3004577686
Location
Massalengo, Lodi
Country
ITALYAddress
Strada Longa 809, No.29, , Massalengo, Lodi, 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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2018 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/21/2018 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/25/2011 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/13/2002 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tecnocosmesi S.p.A.'s FDA import refusal history?
Tecnocosmesi S.p.A. (FEI: 3004577686) has 4 FDA import refusal record(s) in our database, spanning from 5/13/2002 to 8/21/2018.
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. Tecnocosmesi S.p.A.'s FEI number is 3004577686.
What types of violations has Tecnocosmesi S.p.A. received?
Tecnocosmesi S.p.A. has been cited for 3 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 Tecnocosmesi S.p.A. come from?
All FDA import refusal data for Tecnocosmesi S.p.A. 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.