Biopharma Technology, S.C. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3007631439 • Ramos Arizpe, Coahuila de Zaragoza • MEXICO
FEI Number
3007631439
Location
Ramos Arizpe, Coahuila de Zaragoza
Country
MEXICOAddress
Boulevard Industrias No. 4057-A, Col. Zona Industrial, Ramos Arizpe, Ramos Arizpe, Coahuila de Zaragoza, 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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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).
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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
INCONSPICU
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)).
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2015 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/24/2015 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 274COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 8/10/2015 | 54ECL99HERBALS & BOTANICAL TEAS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/14/2015 | 54BGE99MINERAL N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/18/2015 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 238UNSAFE ADD | Southwest Import District Office (SWI-DO) |
| 3/18/2015 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 238UNSAFE ADD | Southwest Import District Office (SWI-DO) |
| 12/23/2014 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3300ALLERGEN | Southwest Import District Office (SWI-DO) |
| 12/23/2014 | 31KHT02TEA, GREEN | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 12/23/2014 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 12/23/2014 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Biopharma Technology, S.C. de R.L. de C.V.'s FDA import refusal history?
Biopharma Technology, S.C. de R.L. de C.V. (FEI: 3007631439) has 10 FDA import refusal record(s) in our database, spanning from 12/23/2014 to 12/10/2015.
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. Biopharma Technology, S.C. de R.L. de C.V.'s FEI number is 3007631439.
What types of violations has Biopharma Technology, S.C. de R.L. de C.V. received?
Biopharma Technology, S.C. de R.L. de C.V. 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 Biopharma Technology, S.C. de R.L. de C.V. come from?
All FDA import refusal data for Biopharma Technology, S.C. de R.L. 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.