Biofarma Natural CMD S.A. de C.V.
⚠️ High Risk
FEI: 3012179807 • Zapopan, Jalisco • MEXICO
FEI Number
3012179807
Location
Zapopan, Jalisco
Country
MEXICOAddress
Industria Zapatera No. 142, Fracc. Zapopan, Zapopanjal. Mexico, Zapopan, Jalisco, 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
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).
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).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 54AGY02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 60BDB20METHIONINE (ACIDIFIER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2021 | 65CDA99NUTRIENT/TONIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/30/2016 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 3/30/2016 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Biofarma Natural CMD S.A. de C.V.'s FDA import refusal history?
Biofarma Natural CMD S.A. de C.V. (FEI: 3012179807) has 5 FDA import refusal record(s) in our database, spanning from 3/30/2016 to 9/24/2025.
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. Biofarma Natural CMD S.A. de C.V.'s FEI number is 3012179807.
What types of violations has Biofarma Natural CMD S.A. de C.V. received?
Biofarma Natural CMD S.A. de C.V. 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 Biofarma Natural CMD S.A. de C.V. come from?
All FDA import refusal data for Biofarma Natural CMD S.A. de C.V. 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.