Kryolan GmbH
⚠️ High Risk
FEI: 1000161942 • Berlin, Berlin • GERMANY
FEI Number
1000161942
Location
Berlin, Berlin
Country
GERMANYAddress
Papierstr. 10, , Berlin, Berlin, Germany
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2012 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Cincinnati District Office (CIN-DO) |
| 3/9/2011 | 53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53CD03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GC01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53CD01EYEBROW PENCIL (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GC01BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/9/2011 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Kryolan GmbH's FDA import refusal history?
Kryolan GmbH (FEI: 1000161942) has 18 FDA import refusal record(s) in our database, spanning from 3/9/2011 to 11/15/2012.
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. Kryolan GmbH's FEI number is 1000161942.
What types of violations has Kryolan GmbH received?
Kryolan GmbH 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 Kryolan GmbH come from?
All FDA import refusal data for Kryolan GmbH 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.