FAB LAURYL LAB.
⚠️ Moderate Risk
FEI: 3004132410 • Port-au-Prince, ouest • HAITI
FEI Number
3004132410
Location
Port-au-Prince, ouest
Country
HAITIAddress
UNKOWN, , Port-au-Prince, ouest, Haiti
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2009 | 61HKL99ANTI-BACTERIAL, N.E.C. | 472NO ENGLISH | Florida District Office (FLA-DO) |
| 8/14/2007 | 68CYY20ANTISEPTIC USED MORE THAN 1 SPECIES | Florida District Office (FLA-DO) | |
| 8/14/2007 | 68CYY20ANTISEPTIC USED MORE THAN 1 SPECIES | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/22/2003 | 53JD03DOUCHES (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FAB LAURYL LAB.'s FDA import refusal history?
FAB LAURYL LAB. (FEI: 3004132410) has 4 FDA import refusal record(s) in our database, spanning from 8/22/2003 to 9/1/2009.
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. FAB LAURYL LAB.'s FEI number is 3004132410.
What types of violations has FAB LAURYL LAB. received?
FAB LAURYL LAB. has been cited for 4 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 FAB LAURYL LAB. come from?
All FDA import refusal data for FAB LAURYL LAB. 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.