EMPACADORA THERBAL SA DE CV
⚠️ Moderate Risk
FEI: 3013135410 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3013135410
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Espana 423, Col. San Juan Xalpa, Iztapalapa, Ciudad De Mexico, Ciudad de Mexico, 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
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).
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.
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
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 4/13/2020 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 11/20/2018 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 7/5/2016 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 7/31/2015 | 66FBY99SUPPRESSANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/24/2015 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/29/2013 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 473LABELING | Southwest Import District Office (SWI-DO) |
| 7/2/2013 | 66FAY99SUPPRESSANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/6/2010 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 1/28/2010 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 1/28/2010 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 12/31/2008 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/20/2008 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 10/22/2007 | 54EYT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 11/13/2006 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is EMPACADORA THERBAL SA DE CV's FDA import refusal history?
EMPACADORA THERBAL SA DE CV (FEI: 3013135410) has 14 FDA import refusal record(s) in our database, spanning from 11/13/2006 to 4/13/2020.
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. EMPACADORA THERBAL SA DE CV's FEI number is 3013135410.
What types of violations has EMPACADORA THERBAL SA DE CV received?
EMPACADORA THERBAL SA DE CV has been cited for 6 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 EMPACADORA THERBAL SA DE CV come from?
All FDA import refusal data for EMPACADORA THERBAL 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.