GALLO LAB, SRL
⚠️ Moderate Risk
FEI: 3017174590 • SANTIAGO • DOMINICAN REPUBLIC
FEI Number
3017174590
Location
SANTIAGO
Country
DOMINICAN REPUBLICAddress
PROL. PADRE DE LAS CASAS #38, LOS MOLINOS, SANTIAGO, , 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2020 | 54YMC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/15/2020 | 56EKH20DOXYCYCLINE (TETRACYCLINES) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/15/2020 | 56EKH20DOXYCYCLINE (TETRACYCLINES) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GALLO LAB, SRL's FDA import refusal history?
GALLO LAB, SRL (FEI: 3017174590) has 3 FDA import refusal record(s) in our database, spanning from 10/15/2020 to 10/15/2020.
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. GALLO LAB, SRL's FEI number is 3017174590.
What types of violations has GALLO LAB, SRL received?
GALLO LAB, SRL 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 GALLO LAB, SRL come from?
All FDA import refusal data for GALLO LAB, SRL 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.