Incosmo S.R.L

⚠️ High Risk

FEI: 3014140682 • Biassono, Monza E della Brianza • ITALY

FEI

FEI Number

3014140682

📍

Location

Biassono, Monza E della Brianza

🇮🇹

Country

ITALY

🏢

Address

Via I Maggio 7, , Biassono, Monza E della Brianza, Italy

High Risk

FDA Import Risk Assessment

51.4

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

5/29/2018

Latest Refusal

2/1/2018

Earliest Refusal

Score Breakdown

Violation Severity

61.0×40%

Refusal Volume

56.7×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11833×

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).

328033×

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.

50831×

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.

17816×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

33016×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

Refusal History

Date	Product	Violations	Division
5/29/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
4/23/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
4/4/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/14/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/14/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/8/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/7/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 3280FRNMFGREG 330UNSAFE COL 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
3/1/2018	85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/26/2018	80MMSLUBRICANT, VAGINAL, PATIENT	118NOT LISTED 3280FRNMFGREG	Division of Southeast Imports (DSEI)
2/26/2018	80MMSLUBRICANT, VAGINAL, PATIENT	118NOT LISTED 178COL ADDED 3280FRNMFGREG 508NO 510(K)	Division of Southeast Imports (DSEI)
2/1/2018	80KMJLUBRICANT, PATIENT	118NOT LISTED 178COL ADDED 3280FRNMFGREG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Incosmo S.R.L's FDA import refusal history?

Incosmo S.R.L (FEI: 3014140682) has 33 FDA import refusal record(s) in our database, spanning from 2/1/2018 to 5/29/2018.

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. Incosmo S.R.L's FEI number is 3014140682.

What types of violations has Incosmo S.R.L received?

Incosmo S.R.L has been cited for 5 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 Incosmo S.R.L come from?

All FDA import refusal data for Incosmo 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.