LABORATORIOS PHARMAMERICAN S.R.L.
⚠️ Moderate Risk
FEI: 3014793352 • Batan, AR-B • ARGENTINA
FEI Number
3014793352
Location
Batan, AR-B
Country
ARGENTINAAddress
Calle 3 Y 6 Parque Ind. General Savio, , Batan, AR-B, 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
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 2/28/2019 | 31KFH04TEA, MIXED (GREEN AND BLACK, ETC.) | 488HEALTH C | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS PHARMAMERICAN S.R.L.'s FDA import refusal history?
LABORATORIOS PHARMAMERICAN S.R.L. (FEI: 3014793352) has 10 FDA import refusal record(s) in our database, spanning from 2/28/2019 to 2/28/2019.
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. LABORATORIOS PHARMAMERICAN S.R.L.'s FEI number is 3014793352.
What types of violations has LABORATORIOS PHARMAMERICAN S.R.L. received?
LABORATORIOS PHARMAMERICAN S.R.L. has been cited for 1 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 LABORATORIOS PHARMAMERICAN S.R.L. come from?
All FDA import refusal data for LABORATORIOS PHARMAMERICAN 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.