Laboratotie Kyrn
⚠️ Moderate Risk
FEI: 3003938186 • Nice, Alpes Maritimes • FRANCE
FEI Number
3003938186
Location
Nice, Alpes Maritimes
Country
FRANCEAddress
13 Rue Alphonse Karr, , Nice, Alpes Maritimes, France
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
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.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2004 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 8/23/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/23/2004 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratotie Kyrn's FDA import refusal history?
Laboratotie Kyrn (FEI: 3003938186) has 7 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 8/23/2004.
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. Laboratotie Kyrn's FEI number is 3003938186.
What types of violations has Laboratotie Kyrn received?
Laboratotie Kyrn has been cited for 5 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 Laboratotie Kyrn come from?
All FDA import refusal data for Laboratotie Kyrn 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.