Sliquid Llc
⚠️ Moderate Risk
FEI: 3009914090 • Dallas, TX • UNITED STATES
FEI Number
3009914090
Location
Dallas, TX
Country
UNITED STATESAddress
2546 Irving Blvd, , Dallas, TX, United States
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 80KMJLUBRICANT, PATIENT | Division of Southeast Imports (DSEI) | |
| 7/26/2016 | 80KMJLUBRICANT, PATIENT | Division of Southeast Imports (DSEI) | |
| 6/8/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 3/24/2016 | 80MMSLUBRICANT, VAGINAL, PATIENT | Division of Southeast Imports (DSEI) | |
| 3/14/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Southeast Imports (DSEI) | |
| 3/9/2016 | 80MMSLUBRICANT, VAGINAL, PATIENT | New Orleans District Office (NOL-DO) | |
| 3/9/2016 | 80KMJLUBRICANT, PATIENT | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 3/11/2015 | 80MMSLUBRICANT, VAGINAL, PATIENT | New Orleans District Office (NOL-DO) | |
| 2/23/2015 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/3/2014 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sliquid Llc's FDA import refusal history?
Sliquid Llc (FEI: 3009914090) has 12 FDA import refusal record(s) in our database, spanning from 1/3/2014 to 8/15/2016.
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. Sliquid Llc's FEI number is 3009914090.
What types of violations has Sliquid Llc received?
Sliquid Llc 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 Sliquid Llc come from?
All FDA import refusal data for Sliquid Llc 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.