Farmaceutici Dotti Ciccarelli Spa
⚠️ Moderate Risk
FEI: 3002564931 • Milan, Milan • ITALY
FEI Number
3002564931
Location
Milan, Milan
Country
ITALYAddress
Via Clemente Prudenzio 13, , Milan, Milan, 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
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).
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.
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 9/17/2010 | 63RIY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/17/2010 | 53LC04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 8/17/2010 | 63RDY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 8/17/2010 | 53LD04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 197COSM COLOR | Division of Southeast Imports (DSEI) |
| 8/17/2010 | 63RDY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2004 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/30/2004 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Farmaceutici Dotti Ciccarelli Spa's FDA import refusal history?
Farmaceutici Dotti Ciccarelli Spa (FEI: 3002564931) has 7 FDA import refusal record(s) in our database, spanning from 8/30/2004 to 9/17/2010.
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. Farmaceutici Dotti Ciccarelli Spa's FEI number is 3002564931.
What types of violations has Farmaceutici Dotti Ciccarelli Spa received?
Farmaceutici Dotti Ciccarelli 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 Farmaceutici Dotti Ciccarelli Spa come from?
All FDA import refusal data for Farmaceutici Dotti Ciccarelli 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.