Industrias Alimenticias Fagal S.R.L.
⚠️ Moderate Risk
FEI: 3005555808 • Santa Cruz • BOLIVIA
FEI Number
3005555808
Location
Santa Cruz
Country
BOLIVIAAddress
Parque Industrial 21 B, , Santa Cruz, , Bolivia
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2006 | 03JGT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03JGT01VANILLA FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03JGT02CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03JGT09FRUIT/FRUIT FLAVORED FILLED/ICED COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03HGT02CHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03HGT09FRUIT/FRUIT FLAVORED PLAIN COOKIES, BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03HGT09FRUIT/FRUIT FLAVORED PLAIN COOKIES, BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
| 9/28/2006 | 03HGT09FRUIT/FRUIT FLAVORED PLAIN COOKIES, BISCUITS AND WAFERS | 324NO ENGLISH | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Industrias Alimenticias Fagal S.R.L.'s FDA import refusal history?
Industrias Alimenticias Fagal S.R.L. (FEI: 3005555808) has 11 FDA import refusal record(s) in our database, spanning from 9/28/2006 to 9/28/2006.
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. Industrias Alimenticias Fagal S.R.L.'s FEI number is 3005555808.
What types of violations has Industrias Alimenticias Fagal S.R.L. received?
Industrias Alimenticias Fagal S.R.L. has been cited for 1 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 Industrias Alimenticias Fagal S.R.L. come from?
All FDA import refusal data for Industrias Alimenticias Fagal S.R.L. 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.