Quinfica Nutramedics Boldo
🚨 Critical Risk
FEI: 3006800203 • Guatemala, Guatemala • GUATEMALA
FEI Number
3006800203
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
13 Calle 1 65 z. 2, , Guatemala, Guatemala, Guatemala
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe violations.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2025 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54AFY05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54ABY22SODIUM ASCORBATE (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2025 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/22/2025 | 54AFY05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2025 | 54ABY22SODIUM ASCORBATE (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Quinfica Nutramedics Boldo's FDA import refusal history?
Quinfica Nutramedics Boldo (FEI: 3006800203) has 21 FDA import refusal record(s) in our database, spanning from 8/22/2025 to 9/26/2025.
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. Quinfica Nutramedics Boldo's FEI number is 3006800203.
What types of violations has Quinfica Nutramedics Boldo received?
Quinfica Nutramedics Boldo 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 Quinfica Nutramedics Boldo come from?
All FDA import refusal data for Quinfica Nutramedics Boldo 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.