Lab Ase
⚠️ Moderate Risk
FEI: 1000168980 • Mon • MONACO
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 6/22/2004 | 53HC02CUTICLE SOFTENERS (MANICURING PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/22/2004 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lab Ase's FDA import refusal history?
Lab Ase (FEI: 1000168980) has 3 FDA import refusal record(s) in our database, spanning from 6/22/2004 to 10/7/2004.
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. Lab Ase's FEI number is 1000168980.
What types of violations has Lab Ase received?
Lab Ase 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 Lab Ase come from?
All FDA import refusal data for Lab Ase 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.