ImportRefusal LogoImportRefusal

Istituto Ganassiini

⚠️ High Risk

FEI: 3003667459 • Milan, Milan • ITALY

FEI

FEI Number

3003667459

📍

Location

Milan, Milan

🇮🇹

Country

ITALY
🏢

Address

Via Pietro Gaggia 16, , Milan, Milan, Italy

High Risk

FDA Import Risk Assessment

63.0
LowModerateHighCritical

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

Statistics

98
Total Refusals
3
Unique Violations
1/28/2025
Latest Refusal
3/5/2012
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
Refusal Volume
73.9×30%
Recency
81.0×20%
Frequency
75.9×10%
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

47177×

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.

11820×

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).

751×

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).

Refusal History

DateProductViolationsDivision
1/28/2025
66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
12/6/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
12/6/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
118NOT LISTED
Atlanta District Office (ATL-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
6/5/2012
66PAQ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Baltimore District Office (BLT-DO)
3/5/2012
53SA13SUNTAN PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OVINE)
118NOT LISTED
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Istituto Ganassiini's FDA import refusal history?

Istituto Ganassiini (FEI: 3003667459) has 98 FDA import refusal record(s) in our database, spanning from 3/5/2012 to 1/28/2025.

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. Istituto Ganassiini's FEI number is 3003667459.

What types of violations has Istituto Ganassiini received?

Istituto Ganassiini has been cited for 3 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 Istituto Ganassiini come from?

All FDA import refusal data for Istituto Ganassiini 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.