AGROHERBOLARIA SA DE CV
⚠️ High Risk
FEI: 3010118557 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
3010118557
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
Boulevard Manuel Gomez Morin 855-5, Los Pirules, San Luis Potosi, San Luis Potosi, San Luis Potosi, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2024 | 31KYY02TEA, GREEN | Division of Southeast Imports (DSEI) | |
| 1/31/2014 | 5.4e+100HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 1/11/2013 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 12/17/2012 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 4/2/2012 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 3/29/2012 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 1/25/2012 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 11/9/2011 | 54EYT32ARNICA (HERBAL & BOTANICAL TEAS) | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 9/2/2011 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 7/26/2011 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is AGROHERBOLARIA SA DE CV's FDA import refusal history?
AGROHERBOLARIA SA DE CV (FEI: 3010118557) has 10 FDA import refusal record(s) in our database, spanning from 7/26/2011 to 3/21/2024.
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. AGROHERBOLARIA SA DE CV's FEI number is 3010118557.
What types of violations has AGROHERBOLARIA SA DE CV received?
AGROHERBOLARIA SA DE CV has been cited for 3 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 AGROHERBOLARIA SA DE CV come from?
All FDA import refusal data for AGROHERBOLARIA 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.