Carlos Alvear Lopez
⚠️ Moderate Risk
FEI: 3021856082 • Jalmolonga Malinalco, Mexico • MEXICO
FEI Number
3021856082
Location
Jalmolonga Malinalco, Mexico
Country
MEXICOAddress
Domicilio Conocido S/N, , Jalmolonga Malinalco, Mexico, Mexico
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2022 | 54FCR83CITRUS AURANTIUM ( HERBAL & BOTANICAL OTHER THAN TEAS) | Division of Southwest Imports (DSWI) | |
| 8/10/2022 | 54FCR88GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | Division of Southwest Imports (DSWI) | |
| 8/10/2022 | 54FCR83CITRUS AURANTIUM ( HERBAL & BOTANICAL OTHER THAN TEAS) | Division of Southwest Imports (DSWI) | |
| 8/10/2022 | 54FCR88GYMNEMA SYLVESTRE (HERBAL & BOTANICALS, NOT TEAS) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Carlos Alvear Lopez's FDA import refusal history?
Carlos Alvear Lopez (FEI: 3021856082) has 4 FDA import refusal record(s) in our database, spanning from 8/10/2022 to 8/10/2022.
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. Carlos Alvear Lopez's FEI number is 3021856082.
What types of violations has Carlos Alvear Lopez received?
Carlos Alvear Lopez 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 Carlos Alvear Lopez come from?
All FDA import refusal data for Carlos Alvear Lopez 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.