R.C.M. S.R.L.
⚠️ High Risk
FEI: 3005416813 • Bergamo • ITALY
FEI Number
3005416813
Location
Bergamo
Country
ITALYAddress
Via Perugino, 2-24068 Seriate, , Bergamo, , 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
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).
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).
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.
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2024 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 11/20/2024 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/18/2014 | 53FD07HAIR BLEACHES (HAIR COLORING PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53CI02EYELINER (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53GH03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 53GH01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/18/2014 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66VIL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is R.C.M. S.R.L.'s FDA import refusal history?
R.C.M. S.R.L. (FEI: 3005416813) has 21 FDA import refusal record(s) in our database, spanning from 12/18/2014 to 11/20/2024.
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. R.C.M. S.R.L.'s FEI number is 3005416813.
What types of violations has R.C.M. S.R.L. received?
R.C.M. S.R.L. 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 R.C.M. S.R.L. come from?
All FDA import refusal data for R.C.M. S.R.L. 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.