DIMEDICS
⚠️ High Risk
FEI: 3020887160 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3020887160
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Km 5 Ca 5, , Tegucigalpa, Francisco Morazan, Honduras
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2022 | 61MCC99ANTI-CONVULSANT, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/12/2022 | 60LBC05ASPIRIN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/10/2022 | 62MBJ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2022 | 56ACZ10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2022 | 56BBC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2022 | 60SBC99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2022 | 64LBK19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/9/2022 | 62PBC99ANTI-PYRETIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 4/29/2022 | 62PBL99ANTI-PYRETIC N.E.C. | Division of Southwest Imports (DSWI) | |
| 4/29/2022 | 62PBY99ANTI-PYRETIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/29/2022 | 56BBC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 62GAC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 62GBL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 56BBC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 56KAZ99MISCELLANEOUS ANTIBIOTICS, N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DIMEDICS's FDA import refusal history?
DIMEDICS (FEI: 3020887160) has 15 FDA import refusal record(s) in our database, spanning from 4/21/2022 to 9/19/2022.
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. DIMEDICS's FEI number is 3020887160.
What types of violations has DIMEDICS received?
DIMEDICS has been cited for 5 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 DIMEDICS come from?
All FDA import refusal data for DIMEDICS 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.