Laboratorios Avant S.A. de C.V.
⚠️ Moderate Risk
FEI: 2000016192 • Parque Industrial Ciudad Mitras, Nuevo Leon • MEXICO
FEI Number
2000016192
Location
Parque Industrial Ciudad Mitras, Nuevo Leon
Country
MEXICOAddress
Calle Cobre 9357, Col. Ciudad Mitras Dos, Garcia, Parque Industrial Ciudad Mitras, Nuevo Leon, 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).
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.
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/19/2013 | 52EYY04PACIFIERS CONTAINING INGESTIBLE FOODS (E.G., HONEY), INFANT FOOD ITEMS | Cincinnati District Office (CIN-DO) | |
| 5/31/2012 | 76KKORING, TEETHING, FLUID-FILLED | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/12/2002 | 76KKORING, TEETHING, FLUID-FILLED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Avant S.A. de C.V.'s FDA import refusal history?
Laboratorios Avant S.A. de C.V. (FEI: 2000016192) has 3 FDA import refusal record(s) in our database, spanning from 9/12/2002 to 2/19/2013.
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 Avant S.A. de C.V.'s FEI number is 2000016192.
What types of violations has Laboratorios Avant S.A. de C.V. received?
Laboratorios Avant S.A. de C.V. has been cited for 4 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 Avant S.A. de C.V. come from?
All FDA import refusal data for Laboratorios Avant 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.