Drogueria Luipharm
⚠️ Moderate Risk
FEI: 3008925269 • Guatemala, Guatemala • GUATEMALA
FEI Number
3008925269
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
Av C 0-39 Zona 2 Mixco 50 Col Molino de, Las Flores, 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
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
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)
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 3/12/2014 | 54ACK02VITAMIN B1 (THIAMINE) | Division of Southeast Imports (DSEI) | |
| 11/22/2013 | 60LCO99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/21/2013 | 54ACK99VITAMIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54FCL20MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54FCK20MINT (HERBAL & BOTANICALS, NOT TEAS - IF TEA FORM SEE 31P) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54ACK06NIACIN (NICOTINIC ACID) (VITAMIN) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54ACK20MENADIONE (VITAMIN) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54ACK02VITAMIN B1 (THIAMINE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54AGK99VITAMIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/21/2013 | 54ACK02VITAMIN B1 (THIAMINE) | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Drogueria Luipharm's FDA import refusal history?
Drogueria Luipharm (FEI: 3008925269) has 20 FDA import refusal record(s) in our database, spanning from 6/21/2013 to 3/12/2014.
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. Drogueria Luipharm's FEI number is 3008925269.
What types of violations has Drogueria Luipharm received?
Drogueria Luipharm has been cited for 6 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 Drogueria Luipharm come from?
All FDA import refusal data for Drogueria Luipharm 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.