Ludovico Martelli spa
⚠️ High Risk
FEI: 3008224249 • Fiesole, Florence • ITALY
FEI Number
3008224249
Location
Fiesole, Florence
Country
ITALYAddress
Via Faentina 169/12, , Fiesole, Florence, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
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.
FALSEDRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug which is misbranded within the meaning of section 502(a)(1) in that its labeling is false or misleading.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/6/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/6/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/6/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 10/30/2024 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southwest Imports (DSWI) | |
| 9/5/2013 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/31/2013 | 53KC06SHAVING SOAP (CAKES, STICKS, ETC.) (SHAVING PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/31/2013 | 53KC06SHAVING SOAP (CAKES, STICKS, ETC.) (SHAVING PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/31/2013 | 53KC06SHAVING SOAP (CAKES, STICKS, ETC.) (SHAVING PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/31/2013 | 53KC06SHAVING SOAP (CAKES, STICKS, ETC.) (SHAVING PREPARATIONS) | New York District Office (NYK-DO) | |
| 5/31/2013 | 53KC06SHAVING SOAP (CAKES, STICKS, ETC.) (SHAVING PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 5/31/2013 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 5/31/2013 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 5/31/2013 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ludovico Martelli spa's FDA import refusal history?
Ludovico Martelli spa (FEI: 3008224249) has 14 FDA import refusal record(s) in our database, spanning from 5/31/2013 to 1/6/2025.
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. Ludovico Martelli spa's FEI number is 3008224249.
What types of violations has Ludovico Martelli spa received?
Ludovico Martelli spa has been cited for 10 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 Ludovico Martelli spa come from?
All FDA import refusal data for Ludovico Martelli 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.