Roemmers Saicf
⚠️ Moderate Risk
FEI: 3004464261 • Buenos Aires • ARGENTINA
FEI Number
3004464261
Location
Buenos Aires
Country
ARGENTINAAddress
Fray Justo Sarmiento 2350, , 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
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2020 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/9/2018 | 56YBY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2007 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/21/2007 | 64HDK99EXPECTORANT N.E.C. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Roemmers Saicf's FDA import refusal history?
Roemmers Saicf (FEI: 3004464261) has 5 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 6/19/2020.
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. Roemmers Saicf's FEI number is 3004464261.
What types of violations has Roemmers Saicf received?
Roemmers Saicf has been cited for 2 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 Roemmers Saicf come from?
All FDA import refusal data for Roemmers Saicf 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.