LABORATORIOS FARMACEUTICOS ENMILEN
⚠️ Moderate Risk
FEI: 3016598545 • Santa Tecla, La Libertad • EL SALVADOR
FEI Number
3016598545
Location
Santa Tecla, La Libertad
Country
EL SALVADORAddress
11 Calle Poniente Blocka#11, Residencia Los Cipreses, Santa Tecla, La Libertad, El Salvador
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
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
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)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2011 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 4/8/2009 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 4/8/2009 | 54YCK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is LABORATORIOS FARMACEUTICOS ENMILEN's FDA import refusal history?
LABORATORIOS FARMACEUTICOS ENMILEN (FEI: 3016598545) has 3 FDA import refusal record(s) in our database, spanning from 4/8/2009 to 2/2/2011.
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 FARMACEUTICOS ENMILEN's FEI number is 3016598545.
What types of violations has LABORATORIOS FARMACEUTICOS ENMILEN received?
LABORATORIOS FARMACEUTICOS ENMILEN has been cited for 3 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 FARMACEUTICOS ENMILEN come from?
All FDA import refusal data for LABORATORIOS FARMACEUTICOS ENMILEN 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.