MOMENTUM
⚠️ Moderate Risk
FEI: 3020783615 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3020783615
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Colonia Palmira, , Tegucigalpa, Francisco Morazan, Honduras
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
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. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 54ACC05VITAMIN B12 (CYANOCOBALAMIN) | 473LABELING | Division of Southeast Imports (DSEI) |
| 8/5/2022 | 62PBH99ANTI-PYRETIC N.E.C. | Division of Southwest Imports (DSWI) | |
| 7/18/2022 | 54AYC90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 308MFR INSAN | Division of Southwest Imports (DSWI) |
| 5/4/2022 | 54ACY90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/21/2022 | 62GAC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MOMENTUM's FDA import refusal history?
MOMENTUM (FEI: 3020783615) has 5 FDA import refusal record(s) in our database, spanning from 4/21/2022 to 10/21/2022.
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. MOMENTUM's FEI number is 3020783615.
What types of violations has MOMENTUM received?
MOMENTUM 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 MOMENTUM come from?
All FDA import refusal data for MOMENTUM 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.