JUST International LATAM S.A.
⚠️ Moderate Risk
FEI: 3007875339 • Buenos Aires • ARGENTINA
FEI Number
3007875339
Location
Buenos Aires
Country
ARGENTINAAddress
Caratini 50, General Rodriguez, Buenos Aires, , 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
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2010 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 7/26/2010 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 6/15/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is JUST International LATAM S.A.'s FDA import refusal history?
JUST International LATAM S.A. (FEI: 3007875339) has 3 FDA import refusal record(s) in our database, spanning from 6/15/2010 to 7/26/2010.
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. JUST International LATAM S.A.'s FEI number is 3007875339.
What types of violations has JUST International LATAM S.A. received?
JUST International LATAM S.A. 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 JUST International LATAM S.A. come from?
All FDA import refusal data for JUST International LATAM S.A. 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.