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C S 33 Fine Chemicals

⚠️ Moderate Risk

FEI: 3003553232 • Milan, Milan • ITALY

FEI

FEI Number

3003553232

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Corso Sempione 33, , Milan, Milan, Italy

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
2/1/2002
Latest Refusal
2/1/2002
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

2231×

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.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

821×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

Refusal History

DateProductViolationsDivision
2/1/2002
61WCY03CICLOPIROX OLAMINE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
118NOT LISTED
223FALSE
336INCONSPICU
82RX LEGEND
Detroit District Office (DET-DO)

Frequently Asked Questions

What is C S 33 Fine Chemicals's FDA import refusal history?

C S 33 Fine Chemicals (FEI: 3003553232) has 1 FDA import refusal record(s) in our database, spanning from 2/1/2002 to 2/1/2002.

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. C S 33 Fine Chemicals's FEI number is 3003553232.

What types of violations has C S 33 Fine Chemicals received?

C S 33 Fine Chemicals has been cited for 4 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 C S 33 Fine Chemicals come from?

All FDA import refusal data for C S 33 Fine Chemicals 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.