Importadora Sudamericana S.R.L.
⚠️ Moderate Risk
FEI: 3003829561 • Buenos Aires • ARGENTINA
FEI Number
3003829561
Location
Buenos Aires
Country
ARGENTINAAddress
Camargo 769, , 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 4/23/2007 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/23/2007 | 53JI02DEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/9/2004 | 60QBH99ANESTHETIC, N.E.C. | New York District Office (NYK-DO) | |
| 3/5/2003 | 85HILTAMPON, MENSTRUAL, SCENTED, DEODORIZED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Importadora Sudamericana S.R.L.'s FDA import refusal history?
Importadora Sudamericana S.R.L. (FEI: 3003829561) has 4 FDA import refusal record(s) in our database, spanning from 3/5/2003 to 4/23/2007.
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. Importadora Sudamericana S.R.L.'s FEI number is 3003829561.
What types of violations has Importadora Sudamericana S.R.L. received?
Importadora Sudamericana S.R.L. 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 Importadora Sudamericana S.R.L. come from?
All FDA import refusal data for Importadora Sudamericana S.R.L. 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.