INVERSIONES Y SERVICIOS FIGUERAS S.A.
⚠️ Moderate Risk
FEI: 2000005458 • Guatemala, Guatemala • GUATEMALA
FEI Number
2000005458
Location
Guatemala, Guatemala
Country
GUATEMALAAddress
39 Avenida 10-65 Z. 7, , Guatemala, Guatemala, Guatemala
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
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)).
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.
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.
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2007 | 76EFWTOOTHBRUSH, MANUAL | Florida District Office (FLA-DO) | |
| 9/22/2006 | 07AGT02CORN CHIPS, BAKED | Florida District Office (FLA-DO) | |
| 9/22/2006 | 07AGT02CORN CHIPS, BAKED | Florida District Office (FLA-DO) | |
| 9/22/2006 | 29BHT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | Florida District Office (FLA-DO) | |
| 9/22/2006 | 30FGT99BEVERAGE BASE OF NON-FRUIT ORIGIN, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 9/22/2006 | 30FGT99BEVERAGE BASE OF NON-FRUIT ORIGIN, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 9/22/2006 | 30GGT99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 9/22/2006 | 30YGT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 9/22/2006 | 50LGT21PAPRIKA | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is INVERSIONES Y SERVICIOS FIGUERAS S.A.'s FDA import refusal history?
INVERSIONES Y SERVICIOS FIGUERAS S.A. (FEI: 2000005458) has 9 FDA import refusal record(s) in our database, spanning from 9/22/2006 to 3/8/2007.
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. INVERSIONES Y SERVICIOS FIGUERAS S.A.'s FEI number is 2000005458.
What types of violations has INVERSIONES Y SERVICIOS FIGUERAS S.A. received?
INVERSIONES Y SERVICIOS FIGUERAS S.A. 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 INVERSIONES Y SERVICIOS FIGUERAS S.A. come from?
All FDA import refusal data for INVERSIONES Y SERVICIOS FIGUERAS S.A. 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.