Comercializadora Nopalitoz Sa De Cv
⚠️ Moderate Risk
FEI: 3005804134 • Monterrey, Nuevo Leon • MEXICO
FEI Number
3005804134
Location
Monterrey, Nuevo Leon
Country
MEXICOAddress
Calle Antiguo Camino a Villa de, Santiago 2903;Col. BALCONES DE ALTAVISTA, Monterrey, Nuevo Leon, 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
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).
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).
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2008 | 61PCY99ANTI-DIABETIC N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/20/2008 | 61PCY99ANTI-DIABETIC N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/14/2007 | 24TGT99LEAF & STEM VEGETABLES, N.E.C. | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 8/22/2006 | 24TGE99LEAF & STEM VEGETABLES, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 8/22/2006 | 24TGE99LEAF & STEM VEGETABLES, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 8/22/2006 | 24TGE99LEAF & STEM VEGETABLES, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Comercializadora Nopalitoz Sa De Cv's FDA import refusal history?
Comercializadora Nopalitoz Sa De Cv (FEI: 3005804134) has 6 FDA import refusal record(s) in our database, spanning from 8/22/2006 to 10/3/2008.
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. Comercializadora Nopalitoz Sa De Cv's FEI number is 3005804134.
What types of violations has Comercializadora Nopalitoz Sa De Cv received?
Comercializadora Nopalitoz Sa De Cv has been cited for 5 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 Comercializadora Nopalitoz Sa De Cv come from?
All FDA import refusal data for Comercializadora Nopalitoz Sa De Cv 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.