Gotha Cosmetics Srl
⚠️ High Risk
FEI: 3005849473 • Lallio, Bergamo • ITALY
FEI Number
3005849473
Location
Lallio, Bergamo
Country
ITALYAddress
Via Vaglietta 3, , Lallio, Bergamo, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/15/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/8/2023 | 66PBL14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/5/2010 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Gotha Cosmetics Srl's FDA import refusal history?
Gotha Cosmetics Srl (FEI: 3005849473) has 12 FDA import refusal record(s) in our database, spanning from 8/5/2010 to 9/15/2023.
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. Gotha Cosmetics Srl's FEI number is 3005849473.
What types of violations has Gotha Cosmetics Srl received?
Gotha Cosmetics Srl has been cited for 2 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 Gotha Cosmetics Srl come from?
All FDA import refusal data for Gotha Cosmetics Srl 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.