Milagro De La Selva, S.A.
⚠️ Moderate Risk
FEI: 3003612034 • Guatemala City • GUATEMALA
FEI Number
3003612034
Location
Guatemala City
Country
GUATEMALAAddress
Diagonal 6 13-94 Zona 10, , Guatemala City, , Guatemala
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 Milagro De La Selva, S.A.'s FDA import refusal history?
Milagro De La Selva, S.A. (FEI: 3003612034) has 1 FDA import refusal record(s) in our database, spanning from 8/11/2008 to 8/11/2008.
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. Milagro De La Selva, S.A.'s FEI number is 3003612034.
What types of violations has Milagro De La Selva, S.A. received?
Milagro De La Selva, 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 Milagro De La Selva, S.A. come from?
All FDA import refusal data for Milagro De La Selva, 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.