CENTRO STYLE S.P.A.
⚠️ Moderate Risk
FEI: 3001018555 • Vedano Olona, Varese • ITALY
FEI Number
3001018555
Location
Vedano Olona, Varese
Country
ITALYAddress
Via Gian Domenico Martinengo 7, , Vedano Olona, Varese, 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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2018 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Northern Border Imports (DNBI) | |
| 9/5/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is CENTRO STYLE S.P.A.'s FDA import refusal history?
CENTRO STYLE S.P.A. (FEI: 3001018555) has 2 FDA import refusal record(s) in our database, spanning from 9/5/2013 to 10/29/2018.
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. CENTRO STYLE S.P.A.'s FEI number is 3001018555.
What types of violations has CENTRO STYLE S.P.A. received?
CENTRO STYLE S.P.A. has been cited for 8 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 CENTRO STYLE S.P.A. come from?
All FDA import refusal data for CENTRO STYLE 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.