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Kan Productions Sarl

⚠️ Moderate Risk

FEI: 3004357084 • Melegnano, Milan • ITALY

FEI

FEI Number

3004357084

📍

Location

Melegnano, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Ventitre Marzo 1848 9, , Melegnano, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
6
Unique Violations
7/18/2019
Latest Refusal
5/24/2017
Earliest Refusal

Score Breakdown

Violation Severity
58.6×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
9.3×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

752×

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).

1781×

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).

3301×

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).

3331×

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

38701×

708NOENGL

Required label or labeling has been determined to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
7/18/2019
64XBY06SALICYLIC ACID (KERATOLYTIC)
330UNSAFE COL
333LACKS FIRM
335LACKS N/C
3870708NOENGL
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/24/2017
64XBK06SALICYLIC ACID (KERATOLYTIC)
178COL ADDED
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Kan Productions Sarl's FDA import refusal history?

Kan Productions Sarl (FEI: 3004357084) has 2 FDA import refusal record(s) in our database, spanning from 5/24/2017 to 7/18/2019.

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. Kan Productions Sarl's FEI number is 3004357084.

What types of violations has Kan Productions Sarl received?

Kan Productions Sarl 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 Kan Productions Sarl come from?

All FDA import refusal data for Kan Productions Sarl 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.