Laboratorios Brovel
⚠️ Moderate Risk
FEI: 3004522060 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004522060
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Empresa No 66, Col. Insurgentes Mixcoac, Benito Juarez, 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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2011 | 54YMZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 4/5/2006 | 60NCL14TESTOSTERONE (ANDROGEN) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 5/27/2004 | 54AMB05VITAMIN B12 (CYANOCOBALAMIN) | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 5/27/2004 | 54ANP05VITAMIN B12 (CYANOCOBALAMIN) | New Orleans District Office (NOL-DO) | |
| 5/27/2004 | 54ANP05VITAMIN B12 (CYANOCOBALAMIN) | New Orleans District Office (NOL-DO) | |
| 5/27/2004 | 54ANP05VITAMIN B12 (CYANOCOBALAMIN) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios Brovel's FDA import refusal history?
Laboratorios Brovel (FEI: 3004522060) has 6 FDA import refusal record(s) in our database, spanning from 5/27/2004 to 10/27/2011.
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. Laboratorios Brovel's FEI number is 3004522060.
What types of violations has Laboratorios Brovel received?
Laboratorios Brovel has been cited for 5 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 Laboratorios Brovel come from?
All FDA import refusal data for Laboratorios Brovel 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.