Vital Maycar S.A.
⚠️ Moderate Risk
FEI: 3003621489 • San Justo, Buenos Aires • ARGENTINA
FEI Number
3003621489
Location
San Justo, Buenos Aires
Country
ARGENTINAAddress
Camino de Cintura Mons Bufano 2950, , San Justo, Buenos Aires, Argentina
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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2010 | 34FFT01CHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 6/4/2010 | 33KFT99SOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 6/4/2010 | 33EFT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 6/4/2010 | 33EFT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 6/4/2010 | 33UFT01BUBBLE GUM (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 6/4/2010 | 33UFT01BUBBLE GUM (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 8/28/2008 | 33LFT06FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 8/28/2008 | 34FFT01CHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 10/1/2007 | 29CHN99NONALCOHOLIC BEVERAGES, N.E.C. | Florida District Office (FLA-DO) | |
| 10/1/2007 | 29CHN99NONALCOHOLIC BEVERAGES, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Vital Maycar S.A.'s FDA import refusal history?
Vital Maycar S.A. (FEI: 3003621489) has 10 FDA import refusal record(s) in our database, spanning from 10/1/2007 to 6/4/2010.
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. Vital Maycar S.A.'s FEI number is 3003621489.
What types of violations has Vital Maycar S.A. received?
Vital Maycar 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 Vital Maycar S.A. come from?
All FDA import refusal data for Vital Maycar 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.