AQUEOS CORPORATION
⚠️ High Risk
FEI: 3035736337 • Broussard, LA • UNITED STATES
FEI Number
3035736337
Location
Broussard, LA
Country
UNITED STATESAddress
1186 Petroleum Pkwy, , Broussard, LA, United States
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
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2025 | 73CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 78EZLCATHETER, RETENTION TYPE, BALLOON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 78EZLCATHETER, RETENTION TYPE, BALLOON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 78FCMTRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 73CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 89IMDPACK, HOT OR COLD, DISPOSABLE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80MMKCONTAINER, SHARPS | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80NGTDEVICE, FLUSH, VASCULAR ACCESS | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 86LXQCUP, EYE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 74DXQCUFF, BLOOD-PRESSURE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FQMBANDAGE, ELASTIC | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 79FRODRESSING, WOUND, DRUG | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FQMBANDAGE, ELASTIC | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FQMBANDAGE, ELASTIC | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 79MGPDRESSING, WOUND AND BURN, OCCLUSIVE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FMFSYRINGE, PISTON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FMFSYRINGE, PISTON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FMFSYRINGE, PISTON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FMFSYRINGE, PISTON | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 79MGPDRESSING, WOUND AND BURN, OCCLUSIVE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 79FRODRESSING, WOUND, DRUG | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 80FMGSTOPCOCK, I.V. SET | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 73BWCNEEDLE, EMERGENCY AIRWAY | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 83ORLT-CELL XTEND REAGENT | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 65FAL06WATER, PURIFIED (EYEWASH) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 61LAY99ANTI-COAGULANT, N.E.C. | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 61PAY99ANTI-DIABETIC N.E.C. | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60QCK07LIDOCAINE | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60QDK67LIDOCAINE (ANESTHETIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60CCK04EPINEPHRINE (ADRENERGIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 61XAA18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60LAA01ACETAMINOPHEN (ANALGESIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60LAA05ASPIRIN (ANALGESIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 62GAA41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 63XAK12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60QAK56BENZOCAINE (ANESTHETIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 65LAK04BENZOIN (TINCT) (PROTECTANT) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 62FAO34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 61FAY21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 62FAO34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 56FAJ14BACITRACIN, N.E.C. (PEPTIDES) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 64LAJ37HYDROCORTISONE (GLUCOCORTICOID) | Division of Southwest Imports (DSWI) | |
| 12/10/2025 | 60LAK99ANALGESIC, N.E.C. | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is AQUEOS CORPORATION's FDA import refusal history?
AQUEOS CORPORATION (FEI: 3035736337) has 52 FDA import refusal record(s) in our database, spanning from 12/10/2025 to 12/10/2025.
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. AQUEOS CORPORATION's FEI number is 3035736337.
What types of violations has AQUEOS CORPORATION received?
AQUEOS CORPORATION has been cited for 3 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 AQUEOS CORPORATION come from?
All FDA import refusal data for AQUEOS CORPORATION 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.