Import & Export Santa Catalina INC.
⚠️ Moderate Risk
FEI: 3004404089 • Cochabamba, BO-C • BOLIVIA
FEI Number
3004404089
Location
Cochabamba, BO-C
Country
BOLIVIAAddress
Av. Petrolera Km. 4 1/2 # 1358, Av. Ayacucho # 127, Cochabamba, BO-C, 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
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.
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.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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 |
|---|---|---|---|
| 6/24/2009 | 28YGY99SPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C. | 260FALSE | Baltimore District Office (BLT-DO) |
| 6/16/2009 | 28YGY99SPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C. | 329JUICE % | Baltimore District Office (BLT-DO) |
| 1/12/2009 | 28AGF16CUMIN, WHOLE (SPICE) | 9SALMONELLA | Baltimore District Office (BLT-DO) |
| 9/4/2007 | 04AFT02MACARONI | Baltimore District Office (BLT-DO) | |
| 9/4/2007 | 33LFT09MARSHMALLOW CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Baltimore District Office (BLT-DO) | |
| 5/3/2007 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 2/1/2006 | 23BGT05COCONUT, SHELLED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Import & Export Santa Catalina INC.'s FDA import refusal history?
Import & Export Santa Catalina INC. (FEI: 3004404089) has 7 FDA import refusal record(s) in our database, spanning from 2/1/2006 to 6/24/2009.
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. Import & Export Santa Catalina INC.'s FEI number is 3004404089.
What types of violations has Import & Export Santa Catalina INC. received?
Import & Export Santa Catalina INC. has been cited for 9 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 Import & Export Santa Catalina INC. come from?
All FDA import refusal data for Import & Export Santa Catalina INC. 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.