TECNO BOTANICA DE MEXICO SA DE CV
⚠️ Moderate Risk
FEI: 3004397191 • MEXICO, MX-DIF • MEXICO
FEI Number
3004397191
Location
MEXICO, MX-DIF
Country
MEXICOAddress
Soledad 92 2do Piso, Merced Balbuena, Deleg. V. Carranza, MEXICO, MX-DIF, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and 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).
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).
UNSAFE SUB
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/5/2012 | 50LGH37ARTEMISIA | 280UNSAFE SUB | Southwest Import District Office (SWI-DO) |
| 3/9/2012 | 54YCF99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 274COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 11/15/2011 | 62GAL99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/9/2011 | 62FAL99ANTI-INFECTIVE, TOPICAL N.E.C. | Southwest Import District Office (SWI-DO) | |
| 10/19/2011 | 62GAL99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 10/5/2011 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 11/16/2007 | 54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 11/16/2007 | 54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 10/30/2007 | 54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 10/30/2007 | 54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 1/5/2007 | 54FCF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 9SALMONELLA | Southwest Import District Office (SWI-DO) |
| 7/7/2006 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is TECNO BOTANICA DE MEXICO SA DE CV's FDA import refusal history?
TECNO BOTANICA DE MEXICO SA DE CV (FEI: 3004397191) has 12 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 9/5/2012.
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. TECNO BOTANICA DE MEXICO SA DE CV's FEI number is 3004397191.
What types of violations has TECNO BOTANICA DE MEXICO SA DE CV received?
TECNO BOTANICA DE MEXICO SA DE CV has been cited for 9 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 TECNO BOTANICA DE MEXICO SA DE CV come from?
All FDA import refusal data for TECNO BOTANICA DE MEXICO 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.