Laboratorios Dispert Sa
⚠️ Moderate Risk
FEI: 3004998972 • Montevideo • URUGUAY
FEI Number
3004998972
Location
Montevideo
Country
URUGUAYAddress
Garibaldi 2797 N P 2, , Montevideo, , Uruguay
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
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
Frequently Asked Questions
What is Laboratorios Dispert Sa's FDA import refusal history?
Laboratorios Dispert Sa (FEI: 3004998972) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 3/29/2005.
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 Dispert Sa's FEI number is 3004998972.
What types of violations has Laboratorios Dispert Sa received?
Laboratorios Dispert Sa 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 Laboratorios Dispert Sa come from?
All FDA import refusal data for Laboratorios Dispert Sa 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.