Agrncia Maritima Nabsa Sa
⚠️ Moderate Risk
FEI: 3010443163 • Buenos Aires, Capital Federal • ARGENTINA
FEI Number
3010443163
Location
Buenos Aires, Capital Federal
Country
ARGENTINAAddress
Pasaje Carlos A Colombo 728, , Buenos Aires, Capital Federal, Argentina
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
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.
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).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/29/2013 | 61TAA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 60WAA31PYRANTEL PAMOATE (ANTHELMINTIC) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 63BBQ02ALBUTEROL SULFATE (BRONCHODILATOR) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 60QAK52TETRACAINE HCL (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 65RBA04CALCIUM GLUCONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 61FAA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 78GBMCATHETER, URETHRAL | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 76EBDCOATING, FILLING MATERIAL, RESIN | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 79GECBRUSH, SCRUB, OPERATING-ROOM | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 79GCBNEEDLE, CATHETER | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 79GAXTOURNIQUET, NONPNEUMATIC | Division of Southeast Imports (DSEI) | |
| 11/29/2013 | 80KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Agrncia Maritima Nabsa Sa's FDA import refusal history?
Agrncia Maritima Nabsa Sa (FEI: 3010443163) has 12 FDA import refusal record(s) in our database, spanning from 11/29/2013 to 11/29/2013.
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. Agrncia Maritima Nabsa Sa's FEI number is 3010443163.
What types of violations has Agrncia Maritima Nabsa Sa received?
Agrncia Maritima Nabsa Sa 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 Agrncia Maritima Nabsa Sa come from?
All FDA import refusal data for Agrncia Maritima Nabsa Sa 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.