Laboratorio San Luis S.A.
⚠️ Moderate Risk
FEI: 3013339761 • Santo Domingo Oeste, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3013339761
Location
Santo Domingo Oeste, Santo Domingo
Country
DOMINICAN REPUBLICAddress
Avenida Los Beisbolistas, Calle 1Ra, Santo Domingo Oeste, Santo Domingo, Dominican Republic
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 |
|---|---|---|---|
| 5/25/2018 | 60LDB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61XCB09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61XDB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61XDB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61XDB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) | |
| 10/4/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Laboratorio San Luis S.A.'s FDA import refusal history?
Laboratorio San Luis S.A. (FEI: 3013339761) has 8 FDA import refusal record(s) in our database, spanning from 10/4/2005 to 5/25/2018.
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. Laboratorio San Luis S.A.'s FEI number is 3013339761.
What types of violations has Laboratorio San Luis S.A. received?
Laboratorio San Luis S.A. 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 Laboratorio San Luis S.A. come from?
All FDA import refusal data for Laboratorio San Luis 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.