LACTEOS DE AGALTA
⚠️ Moderate Risk
FEI: 3021618545 • Agalta, Olancho • HONDURAS
FEI Number
3021618545
Location
Agalta, Olancho
Country
HONDURASAddress
Agalta, , Agalta, Olancho, 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
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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)).
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.
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.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2022 | 09CGT12CREAM, SOUR | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 12AGT60CHEESE, SWISS, EMMENTALER | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 09CGT12CREAM, SOUR | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/21/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/19/2022 | 09CGT12CREAM, SOUR | Division of Southeast Imports (DSEI) | |
| 8/23/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | 308MFR INSAN | Division of Southeast Imports (DSEI) |
| 8/23/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | 308MFR INSAN | Division of Southeast Imports (DSEI) |
| 8/5/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | Division of Southwest Imports (DSWI) | |
| 8/5/2022 | 09CGT12CREAM, SOUR | Division of Southwest Imports (DSWI) | |
| 8/4/2022 | 09CGT12CREAM, SOUR | Division of Southwest Imports (DSWI) | |
| 6/30/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | 324NO ENGLISH | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 09CGT12CREAM, SOUR | 324NO ENGLISH | Division of Northern Border Imports (DNBI) |
| 6/30/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | 324NO ENGLISH | Division of Northern Border Imports (DNBI) |
| 6/6/2022 | 12AGT19CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is LACTEOS DE AGALTA's FDA import refusal history?
LACTEOS DE AGALTA (FEI: 3021618545) has 14 FDA import refusal record(s) in our database, spanning from 6/6/2022 to 11/8/2022.
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. LACTEOS DE AGALTA's FEI number is 3021618545.
What types of violations has LACTEOS DE AGALTA received?
LACTEOS DE AGALTA has been cited for 10 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 LACTEOS DE AGALTA come from?
All FDA import refusal data for LACTEOS DE AGALTA 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.