Laboratorios Aranda, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003432025 • Queretaro, QRO • MEXICO
FEI Number
3003432025
Location
Queretaro, QRO
Country
MEXICOAddress
San Martin de Porres No. 105, Fracc.Ind. Carillo Puerto, Queretaro, QRO, 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
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 8/20/2002 | 68KBJ20WOUND DRESSING USED MORE THAN 1 SPECIES | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 68KIJ20WOUND DRESSING USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 68KIJ20WOUND DRESSING USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 68KIJ20WOUND DRESSING USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) | |
| 12/28/2001 | 68KIJ20WOUND DRESSING USED MORE THAN 1 SPECIES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Aranda, S.A. de C.V.'s FDA import refusal history?
Laboratorios Aranda, S.A. de C.V. (FEI: 3003432025) has 6 FDA import refusal record(s) in our database, spanning from 12/28/2001 to 8/20/2002.
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 Aranda, S.A. de C.V.'s FEI number is 3003432025.
What types of violations has Laboratorios Aranda, S.A. de C.V. received?
Laboratorios Aranda, S.A. de C.V. has been cited for 2 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 Aranda, S.A. de C.V. come from?
All FDA import refusal data for Laboratorios Aranda, 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.