Laboratorios Sierra, Sucs
⚠️ Moderate Risk
FEI: 3004699249 • Guatemala, Guatemala • GUATEMALA
FEI Number
3004699249
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Calzada Roosevelt 41-51 z. 11, , Guatemala, Guatemala, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 Sierra, Sucs's FDA import refusal history?
Laboratorios Sierra, Sucs (FEI: 3004699249) has 1 FDA import refusal record(s) in our database, spanning from 4/16/2007 to 4/16/2007.
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 Sierra, Sucs's FEI number is 3004699249.
What types of violations has Laboratorios Sierra, Sucs received?
Laboratorios Sierra, Sucs 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 Sierra, Sucs come from?
All FDA import refusal data for Laboratorios Sierra, Sucs 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.