ADVACARE PHARMA
⚠️ Moderate Risk
FEI: 3036025203 • Guatamala City • GUATEMALA
FEI Number
3036025203
Location
Guatamala City
Country
GUATEMALAAddress
14 Avenida 1-61 Zona 3, , Guatamala 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
Frequently Asked Questions
What is ADVACARE PHARMA's FDA import refusal history?
ADVACARE PHARMA (FEI: 3036025203) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2025 to 4/11/2025.
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. ADVACARE PHARMA's FEI number is 3036025203.
What types of violations has ADVACARE PHARMA received?
ADVACARE PHARMA 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 ADVACARE PHARMA come from?
All FDA import refusal data for ADVACARE PHARMA 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.