Productos Lacteos
⚠️ Moderate Risk
FEI: 3002879099 • Tequcigalfa • HONDURAS
FEI Number
3002879099
Location
Tequcigalfa
Country
HONDURASAddress
Centro Americanos, , Tequcigalfa, , 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).
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
USUAL NAME
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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2005 | 12BFO13CHEESE, PASTEURIZED, PROCESS (STANDARDIZED) | Division of Southeast Imports (DSEI) | |
| 3/29/2005 | 09AGC01BUTTER (PLAIN OR WHIPPED) | Division of Southeast Imports (DSEI) | |
| 3/31/2004 | 56BDB05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/31/2004 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/31/2004 | 64GDB19ETHINYL ESTRADIOL (ESTROGEN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/31/2004 | 60LBA05ASPIRIN (ANALGESIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/31/2004 | 56EDB99TETRACYCLINE N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Productos Lacteos's FDA import refusal history?
Productos Lacteos (FEI: 3002879099) has 7 FDA import refusal record(s) in our database, spanning from 3/31/2004 to 4/20/2005.
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. Productos Lacteos's FEI number is 3002879099.
What types of violations has Productos Lacteos received?
Productos Lacteos has been cited for 7 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 Productos Lacteos come from?
All FDA import refusal data for Productos Lacteos 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.