Gamma Croma S.P.A.
⚠️ Moderate Risk
FEI: 3005727577 • Vaiano Cremasco, Cremona • ITALY
FEI Number
3005727577
Location
Vaiano Cremasco, Cremona
Country
ITALYAddress
Km 29, Strada Statale Paullese 415, Vaiano Cremasco, Cremona, Italy
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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).
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/20/2011 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | New York District Office (NYK-DO) |
| 10/20/2011 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | New York District Office (NYK-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 10/20/2010 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 11/20/2008 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 1/2/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/30/2004 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Gamma Croma S.P.A.'s FDA import refusal history?
Gamma Croma S.P.A. (FEI: 3005727577) has 25 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 10/20/2011.
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. Gamma Croma S.P.A.'s FEI number is 3005727577.
What types of violations has Gamma Croma S.P.A. received?
Gamma Croma S.P.A. 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 Gamma Croma S.P.A. come from?
All FDA import refusal data for Gamma Croma S.P.A. 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.