INGLOT Sp. z o. o
⚠️ Moderate Risk
FEI: 3007608480 • Przemysl, Podkarpackie • POLAND
FEI Number
3007608480
Location
Przemysl, Podkarpackie
Country
POLANDAddress
ul. Lwowska 154, , Przemysl, Podkarpackie, Poland
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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/26/2019 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 12/26/2019 | 53CK01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 6/24/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/24/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/24/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is INGLOT Sp. z o. o's FDA import refusal history?
INGLOT Sp. z o. o (FEI: 3007608480) has 5 FDA import refusal record(s) in our database, spanning from 6/24/2011 to 12/26/2019.
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. INGLOT Sp. z o. o's FEI number is 3007608480.
What types of violations has INGLOT Sp. z o. o received?
INGLOT Sp. z o. o 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 INGLOT Sp. z o. o come from?
All FDA import refusal data for INGLOT Sp. z o. o 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.