BAYER ANDINA
⚠️ Moderate Risk
FEI: 3021428558 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3021428558
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Parque Comercial Los Proceres Noveno Piso, Edificio Nova 2, , 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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 54AYL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 60IBR12SODIUM CITRATE (ALKALIZER) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/9/2022 | 60IBR12SODIUM CITRATE (ALKALIZER) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is BAYER ANDINA's FDA import refusal history?
BAYER ANDINA (FEI: 3021428558) has 3 FDA import refusal record(s) in our database, spanning from 5/9/2022 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. BAYER ANDINA's FEI number is 3021428558.
What types of violations has BAYER ANDINA received?
BAYER ANDINA 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 BAYER ANDINA come from?
All FDA import refusal data for BAYER ANDINA 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.