Agua Virgen, S. de R.L.
⚠️ Moderate Risk
FEI: 3005220771 • San Luis Rio Colorado, Sonora • MEXICO
FEI Number
3005220771
Location
San Luis Rio Colorado, Sonora
Country
MEXICOAddress
Ave. Felix Contreras # 2400, Barrio Residencias, San Luis Rio Colorado, San Luis Rio Colorado, Sonora, Mexico
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
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.
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.
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2006 | 54YYL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/26/2006 | 29YCY99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/26/2006 | 54YYL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/26/2006 | 54YYL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/26/2006 | 29YCY99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/29/2006 | 29WCT99WATER AND ICE, N.E.C. | 218LIST INGRE | Southwest Import District Office (SWI-DO) |
| 6/29/2006 | 29YCY99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | 218LIST INGRE | Southwest Import District Office (SWI-DO) |
| 3/14/2006 | 65LBY99PROTECTANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/28/2005 | 86HPNMAGNET, PERMANENT | 237NO PMA | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Agua Virgen, S. de R.L.'s FDA import refusal history?
Agua Virgen, S. de R.L. (FEI: 3005220771) has 9 FDA import refusal record(s) in our database, spanning from 9/28/2005 to 9/26/2006.
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. Agua Virgen, S. de R.L.'s FEI number is 3005220771.
What types of violations has Agua Virgen, S. de R.L. received?
Agua Virgen, S. de R.L. has been cited for 11 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 Agua Virgen, S. de R.L. come from?
All FDA import refusal data for Agua Virgen, S. de 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.